# QbD Group > QbD Group is a life sciences consulting firm (600+ experts, founded 2012 in Belgium) that guides > pharmaceutical, biotech, medical device, IVD and combination product companies from idea to patient > across regulatory affairs, quality assurance, clinical operations, pharmacovigilance, toxicology, > laboratory services and software/computer system compliance. ## Facts - Website: https://qbdgroup.com - Legal name: QbD Group NV - Founded: 2012, Belgium - Headquarters: Groenenborgerlaan 16, 2610 Wilrijk, Belgium - Team: 600+ life sciences consultants - Regions served: Europe (BE, NL, ES, PT, DE, CH, SE), United States, Asia - Industries: pharmaceuticals, biotech, ATMP, medical devices, IVD, combination products, companion diagnostics, cosmetics, food supplements - Regulatory frameworks covered: EU MDR 2017/745, EU IVDR 2017/746, FDA QMSR, ISO 13485, ISO 14971, GxP (GMP/GCP/GVP/GLP), EU Annex 1, ICH guidelines, EU AI Act, GAMP 5, 21 CFR Part 11 - Languages: English (/en), Spanish (/es), Simplified Chinese (/zh-cn) - Contact: +32 3 844 45 01 — https://qbdgroup.com/en/contact - LinkedIn: https://www.linkedin.com/company/qbd-group ## Key Pages - [Home](https://qbdgroup.com/en): Life sciences consulting overview. - [Services](https://qbdgroup.com/en/services): Regulatory, quality, clinical, PV, tox, lab and software services. - [Solutions](https://qbdgroup.com/en/solutions): Strategic programmes across the product lifecycle. - [Industries](https://qbdgroup.com/en/industries): Sector-specific expertise (pharma, medtech, IVD, ATMP). - [About QbD Group](https://qbdgroup.com/en/about-qbd): Company, mission, leadership, offices. - [Our Team](https://qbdgroup.com/en/team): Named experts and their specialisms. - [Certifications](https://qbdgroup.com/en/certifications): Accreditations and quality certifications. - [Knowledge Center](https://qbdgroup.com/en/knowledge-center): All published expertise. - [Regulatory Glossary](https://qbdgroup.com/en/knowledge-center/glossary): Definitions of life sciences regulatory terms. - [Blog](https://qbdgroup.com/en/blog): Expert articles. - [Regulatory Updates](https://qbdgroup.com/en/regulatory-updates): Analysis of regulatory change. - [White Papers](https://qbdgroup.com/en/whitepapers): In-depth technical guides. - [Case Studies](https://qbdgroup.com/en/case-studies): Client outcomes. - [Webinars](https://qbdgroup.com/en/webinars): Live and on-demand sessions. - [Events](https://qbdgroup.com/en/events): Conferences and summits. - [Company News](https://qbdgroup.com/en/news): Announcements. - [Contact](https://qbdgroup.com/en/contact): Talk to an expert. ## Localized Entry Points - Spanish: [Inicio](https://qbdgroup.com/es), [Servicios](https://qbdgroup.com/es/servicios), [Industrias](https://qbdgroup.com/es/industrias), [Blog](https://qbdgroup.com/es/blog), [Glosario](https://qbdgroup.com/es/recursos/glosario) - Simplified Chinese: [首页](https://qbdgroup.com/zh-cn), [服务](https://qbdgroup.com/zh-cn/services), [行业](https://qbdgroup.com/zh-cn/industries), [博客](https://qbdgroup.com/zh-cn/blog) ## Solutions - [Market Entry into Europe for Pharma & Biotech](https://qbdgroup.com/en/industries/pharma-biotech/landing-in-europe) End-to-end regulatory, quality, and market access support for pharmaceutical and biotech companies entering the European market. - [Emerging Biotech](https://qbdgroup.com/en/industries/pharma-biotech/emerging-biotech) Dedicated regulatory, CMC, clinical, and quality support for emerging biotech companies developing novel therapies. - [Manufacturing Quality & Compliance](https://qbdgroup.com/en/industries/pharma-biotech/manufacturing-quality-compliance) GMP compliance, quality systems, and manufacturing excellence for pharmaceutical production and aseptic manufacturing. - [Life Cycle Management for Pharma & Biotech](https://qbdgroup.com/en/industries/pharma-biotech/life-cycle-management) End-to-end product lifecycle support including CMC variations, pharmacovigilance, batch release, and post-market surveillance. - [Market Entry into Europe for MedTech](https://qbdgroup.com/en/industries/medical-devices/your-medtech-gateway-to-europe) CE marking, MDR/IVDR compliance, and market access support for medical device and IVD companies entering Europe. - [Emerging MedTech](https://qbdgroup.com/en/industries/medical-devices/startups) Regulatory, quality, and clinical support for MedTech startups and scale-ups bringing innovative devices to market. - [Medical Device Software](https://qbdgroup.com/en/industries/medical-devices/medical-device-software) MDSW qualification, classification, IEC 62304 compliance, cybersecurity, and AI Act support for medical device software. - [Life Cycle Management for Medical Devices and Diagnostics](https://qbdgroup.com/en/industries/medical-devices/life-cycle-management) Post-market surveillance, design change management, technical file maintenance, and re-certification under MDR/IVDR. - [PrecisionDx (CDx)](https://qbdgroup.com/en/industries/companion-diagnostics) End-to-end companion diagnostics and precision medicine expertise, synchronizing Pharma and IVD workstreams. - [Combination Products](https://qbdgroup.com/en/industries/combination-products) Navigating EU and US regulatory pathways for drug-device and biologic-device combination products. ## Services - [QMS Implementation](https://qbdgroup.com/en/services/quality-assurance/qms-setup) Optimize your quality management system with QbD's tailored QMS Setup services. Build a smart, scalable system that aligns with regulatory standards and drives value. - [Clinical Trial Operations](https://qbdgroup.com/en/services/clinical-solutions/clinical-study-operations) Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate. - [PDE-OEL Reports](https://qbdgroup.com/en/services/toxicology/pde-oel-reports) We have a professional team of expert toxicologists to calculate the PDE value of any API and we offer the largest online library of high quality PDE reports. - [Operational Software Compliance](https://qbdgroup.com/en/services/software-solutions-services/operational-software-compliance) Need seamless operational software compliance? QbD ensures your systems meet industry regulations, enhancing data security and reliability. - [QC Chemical Analysis](https://qbdgroup.com/en/services/lab-services/chemical-analysis) Our GP certified QC laboratory can support your analytical needs from pharmacopoeial analysis of raw materials, active pharmaceutical ingredients (APIs), and investigational medicinal products (IMPs) - [RA Strategy for Pharma](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-strategy-pharma) Bringing your pharmaceuticals to the market requires a tailor-made strategy. We can help you to form that strategy and make it a success. - [Commissioning](https://qbdgroup.com/en/services/qualification-validation/commissioning) Commissioning is crucial for getting your systems and equipment to perform at their best and safest. QbD Group is the expert in making sure your systems, utilities, facilities and equipment are up and - [QPPV / Local Representative](https://qbdgroup.com/en/services/pharmacovigilance/qppv-local-representative) Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide. - [Drug Development](https://qbdgroup.com/en/services/regulatory-affairs/drug-development) New pharmaceuticals must be manufactured to high-quality standards before they can be placed on the market. We support you from drug discovery to pre-clinical and clinical testing. - [QMS Remediation & Support](https://qbdgroup.com/en/services/quality-assurance/qms-remediation-support) Achieve operational excellence with QbD's QMS Remediation & Support services. Address gaps, sustain certification, and maintain smooth operations seamlessly. - [Method Development](https://qbdgroup.com/en/services/lab-services/method-development) Method development and validation are essential to the drug development process to ensure the methods are well-defined and fit-for-purpose, and the results are robust and reliable. - [ICSR Management](https://qbdgroup.com/en/services/pharmacovigilance/icsr-management) Maintain compliance and protect patient safety with QbD's expert management of individual case safety reports (ICSRs). Simplify safety reporting processes for clinical trials and marketed products. - [Medical Writing for Medical Devices](https://qbdgroup.com/en/services/clinical-solutions/medical-writing-for-medical-devices) Our expert team of knowledgeable writers will be happy to develop the right document for your needs, from the early phases to post-approval. - [Digitalization](https://qbdgroup.com/en/services/software-solutions-services/digitalization) Our expertise in software implementation and IT partnerships ensures a seamless transition from traditional methods to advanced digital solutions. - [Facility Qualification](https://qbdgroup.com/en/services/qualification-validation/facility-qualification) Confirm that your facilities and HVAC, cleanrooms, and monitoring systems, meet predetermined specifications and regulatory requirements. - [Nitrosamine Risk Assessment](https://qbdgroup.com/en/services/toxicology/nitrosamine-risk-assessment) Elaboration of comprehensive Nitrosamine Risk Assessment reports to ensure pharmaceutical product compliance with regulatory requirements. - [QA Outsourcing](https://qbdgroup.com/en/services/quality-assurance/outsourced-qa) Simplify compliance and reduce costs with QbD Group's Outsourced QA solutions. Tailored support to manage your QMS or specific quality functions effectively. - [Extractables & Leachables Reports](https://qbdgroup.com/en/services/toxicology/extractables-leachables-reports) Our extractables and leachables reports meet the highest quality standards. With rigorous scientific methodology and deep industry expertise. - [Utility Qualification](https://qbdgroup.com/en/services/qualification-validation/utility-qualification) Identify and mitigate risks associated with facility and utility failures such as water systems (WFI, ROW…), gas systems and distribution networks. - [Early Development](https://qbdgroup.com/en/services/regulatory-affairs/early-development) We can maximize your success by leveraging our expertise in regulatory consultations and strategic planning for First-in-Human trials. - [Method Validation](https://qbdgroup.com/en/services/lab-services/method-validation) To ensure that the methods meet regulatory requirements, we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidelines in combination with client-specific protocols. - [Medical Device Software Compliance](https://qbdgroup.com/en/services/software-solutions-services/medical-device-software-compliance) Our service offers a tailor-made framework for medical device software compliance, ensuring adherence to MDR, IVDR, ISO13485, and other key standards. - [Pharmacovigilance & Certified Blended Training](https://qbdgroup.com/en/services/pharmacovigilance/pharmacovigilance-certified-blended-training) Empower your team with our certified pharmacovigilance training. Tailored courses to ensure compliance, mitigate risks, and enhance operational excellence. - [Clinical Regulatory Services](https://qbdgroup.com/en/services/clinical-solutions/clinical-regulatory-services) We help our sponsors conduct their clinical studies in Europe and beyond by expertly navigating both EU MDR and FDA pathways. Our regulatory guidance streamlines the approval process and supports fast - [Scientific Advice](https://qbdgroup.com/en/services/regulatory-affairs/scientific-advice) Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Our regulatory experts can help you to interact with the required health agencies. - [Qualified Person (QP) & Responsible Person (RP)](https://qbdgroup.com/en/services/quality-assurance/qualified-person-qp-responsible-person-rp) Meet regulatory requirements with QbD Group's QP/RP services. Rely on expert support for batch release, GMP/GDP compliance, and operational continuity. - [Safety Reporting & Signal Detection](https://qbdgroup.com/en/services/pharmacovigilance/aggregate-safety-reporting) Optimize your aggregate safety reporting with customized solutions from QbD. Manage risks, meet regulatory standards, and uphold patient safety. - [Stability Studies](https://qbdgroup.com/en/services/lab-services/stability-studies) Investigating the stability and shelf-life of a finished product is an important area of expertise at QbD Group's Lab Services. We can help you determine the best approach for investigating the stabil - [Experts in IVD Clinical Performance Studies](https://qbdgroup.com/en/services/clinical-solutions/ivd-clinical-performance-studies) Do you need compliant clinical evidence for your IVD device? Our IVD experts are happy to support you in your IVD Performance Evaluation Studies. - [AI/ML Compliance](https://qbdgroup.com/en/services/software-solutions-services/ai-ml-compliance) Looking for guidance while developing software including AI-models? QbD offers AI/ML compliance support helping you be compliant with the latest standards and regulations. - [Equipment Qualification](https://qbdgroup.com/en/services/qualification-validation/equipment-qualification) Ensuring that machinery, instruments, or systems used in production, testing, or any other processes consistently perform as intended. - [Environmental Risk Assessment (ERA)](https://qbdgroup.com/en/services/toxicology/environmental-risk-assessment-era) Assess the environmental profile of your pharmaceutical products with our detailed report. Identify and mitigate the environmental risks. - [Regulatory Intelligence](https://qbdgroup.com/en/services/pharmacovigilance/regulatory-intelligence) Stay ahead of evolving regulations with QbD's regulatory intelligence services. Anticipate changes, address potential risks, and streamline compliance with informed, data-driven insights. - [Data Governance](https://qbdgroup.com/en/services/software-solutions-services/data-governance) QbD Group offers data governance support, helping you comply with the latest regulations and shorten your path to market. - [Annual Product Review (APR) & Product Quality Review (PQR)](https://qbdgroup.com/en/services/quality-assurance/annual-product-review-apr-product-quality-review-pqr) Streamline APR/PQR processes with QbD Group's expert support. Ensure compliance, timely reviews, and actionable insights for product quality and safety. - [Regulatory Procedures](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-procedures) There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. Our experts will lead you to the right path. - [Elemental Impurities Reports](https://qbdgroup.com/en/services/toxicology/elemental-impurities-reports) Ensure compliance with elemental impurities regulations through QbD Group's expert risk assessments and tailored reports. - [Cleaning Validation](https://qbdgroup.com/en/services/lab-services/cleaning-validation) Effective cleaning is essential to protect patient safety, and we can help you define a best practice approach in setting up plans and protocols for cleaning validation. - [Process Validation](https://qbdgroup.com/en/services/qualification-validation/process-validation) Our experts are pleased to set up, improve and support the validation of your processes. - [Post-Market Clinical Follow-up](https://qbdgroup.com/en/services/clinical-solutions/pmcf/) Ensure EU MDR 2017/745 compliance with thorough pre-market and post-market processes. Validate device safety with robust data and proactive Post-Market Surveillance (PMS). Use PMCF activities for ongo - [Data Integrity](https://qbdgroup.com/en/services/software-solutions-services/data-integrity) Ensure your data's accuracy and consistency with our tailored data integrity services. We provide expert guidance on complying with 21 CFR Part 11 and EU Annex 11. - [Medical Writing for In Vitro Diagnostics](https://qbdgroup.com/en/services/clinical-solutions/medical-writing-for-in-vitro-diagnostics) We offer writing, consulting, and documentation services for manufacturers of in vitro diagnostics and companion diagnostics - [Residual Solvent Testing (GC)](https://qbdgroup.com/en/services/lab-services/residual-solvent-testing-gc) Reliable GMP-aligned residual solvent testing (GC) for APIs and finished products, ensuring compliance and patient safety. - [Submissions](https://qbdgroup.com/en/services/regulatory-affairs/submissions) Your applications for marketing authorization must be accompanied correctly by the required documentation. Our Regulatory Affairs team will help you to get your documents right. - [Cleaning Validation](https://qbdgroup.com/en/services/qualification-validation/cleaning-validation) QbD Group can support you in the validation and qualification of your cleanrooms, making sure your equipment is truly squeaky clean. - [Pharmacovigilance QMS & PSMF](https://qbdgroup.com/en/services/pharmacovigilance/qms-psmf-services) Streamline your pharmacovigilance compliance with QbD's tailored QMS & PSMF services. Ensure efficiency, audit readiness, and global regulatory alignment. - [QA Audits & Remediation](https://qbdgroup.com/en/services/quality-assurance/audits-and-remediation) Audits are viewed as a necessity. We strive to see any audit as an opportunity to gain more insights into the company itself and the quality management system, which ultimately leads to continuous imp - [Organic Impurities Reports](https://qbdgroup.com/en/services/toxicology/organic-impurities-reports) We carry out toxicological evaluations of organic impurities according to ICH Q3A/B, assessing the toxicological risk and establishing a safety limit. - [Residual Solvents Reports](https://qbdgroup.com/en/services/toxicology/residual-solvents-reports) Ensure compliance and patient safety with QbD Group's residual solvent risk assessments, tailored to meet regulatory standards. - [eCTD Publishing](https://qbdgroup.com/en/services/regulatory-affairs/ectd-publishing) The skills needed to confidently compile electronic submissions can take years of training. Let us be your guide for electronic submissions. - [Software Implementations](https://qbdgroup.com/en/services/software-solutions-services/software-implementations) Transform your life science organization with our expert software implementation services. Our team ensures seamless integration and compliance. - [QMSR Compliance](https://qbdgroup.com/en/services/quality-assurance/qmsr-compliance) Align your quality system with the FDA's new rule (21 CFR Part 820 / ISO 13485:2016) and stay inspection-ready in the US market. Gap assessment, remediation, and inspection readiness for medical devic - [Clinical Strategy Support](https://qbdgroup.com/en/services/clinical-solutions/clinical-strategy-support) We can assist manufacturers by assembling a team of experts with diverse knowledge and backgrounds, such as physicians and clinical experts, to ensure all necessary perspectives are considered when bu - [Analytical Method Validation](https://qbdgroup.com/en/services/qualification-validation/analytical-method-validation) QbD Qualification & Validation uses advanced tools and strict testing methods to ensure your analytical methods are accurate, precise, and reliable. - [Pharmacovigilance (PV) Audits](https://qbdgroup.com/en/services/pharmacovigilance/pv-audits-inspections-quality-system-management) Ensure compliance & inspection readiness with QbD's certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now. - [Microbiological Services](https://qbdgroup.com/en/services/lab-services/microbiological-analysis) We can support you with routine testing and validation of the microbiological purity of raw materials and finished medicinal products. - [Medical Information Services](https://qbdgroup.com/en/services/pharmacovigilance/comprehensive-medical-information-services) Enhance patient safety and product trust with QbD Group's expert medical information services, ensuring timely, accurate responses and compliance throughout your product lifecycle. - [REACH Registration & Compliance](https://qbdgroup.com/en/services/toxicology/reach-registration-compliance-support) Get expert support for REACH registration: substance ID, IUCLID dossiers, SDS, and CSR. Ensure compliance and streamline submissions with QbD Group. - [Sterilization Validation](https://qbdgroup.com/en/services/qualification-validation/sterilization-validation) Ensure that your sterilization processes meet the most stringent standards, ensuring the integrity of your products and safeguarding public health. - [IT Infrastructure Qualification](https://qbdgroup.com/en/services/software-solutions-services/it-infrastructure-qualification) Ensure your IT systems meet regulatory standards with our IT infrastructure qualification services. - [Clinical Pharmacovigilance Service](https://qbdgroup.com/en/services/clinical-solutions/clinical-pharmacovigilance-service) Ensuring comprehensive safety oversight is essential in clinical trials. Our expertise in pharmacovigilance could offer invaluable support. - [Elemental Impurities](https://qbdgroup.com/en/services/lab-services/elemental-impurities) ICH Q3 described expectations regarding the control of elemental impurities in medicinal products or their excipients. A control strategy should be implemented if the risk assessment shows that a sour - [Toxicology](https://qbdgroup.com/en/services/toxicology) QbD Group offers a set of Toxicology services, for your processes, applications, and equipment. We are EUROTOX certified and are members of AETOX. - [Artwork & Labeling](https://qbdgroup.com/en/services/regulatory-affairs/artwork-labeling) Artwork and labeling play an important role in the marketing process of any pharmaceutical and are highly regulated. - [Paperless Validation](https://qbdgroup.com/en/services/software-solutions-services/paperless-validation) Transform your validation process with our Paperless Validation service, offering a digital, efficient, and error-free solution for regulated industries. - [Data Management and Analysis](https://qbdgroup.com/en/services/clinical-solutions/data-management-and-analysis) Clinical data management leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. The clinical data manager oversees the development of data collection too - [QP Batch Release](https://qbdgroup.com/en/services/lab-services/qp-release-and-eu-import) Our Lab Services have authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC. Our own qualified persons (QPs) can certify the batch release testing. - [Tech Transfer](https://qbdgroup.com/en/services/qualification-validation/tech-transfer) Tech Transfer is a vital process in translating innovation into real-world applications. Ensure a smooth transition and successful implementation with us at your side. - [Lifecycle Management](https://qbdgroup.com/en/services/regulatory-affairs/lifecycle-management) Our experts will accompany you throughout the whole Product Life Cycle Management process – from its conception, through design and manufacture, to service and disposal. - [Monitoring Studies](https://qbdgroup.com/en/services/toxicology/monitoring-studies) Keep up to date with standards and ensure the safety of your product. With more than 10 years providing Toxicology Services, membership to AETOX and certified by EUROTOX. - [Clinical Safety Management](https://qbdgroup.com/en/services/clinical-solutions/clinical-safety-management) Ensure safety and compliance in clinical trials with QbD Group's expert Clinical Safety Management solutions. Tailored to meet your trial needs. - [Process & Product Support](https://qbdgroup.com/en/services/qualification-validation/process-product-support) In today's competitive marketplace, optimization of processes and products can make a real difference. Working with QbD Group, you can trust that your processes and products will receive the support a - [Environmental Monitoring](https://qbdgroup.com/en/services/lab-services/environmental-monitoring) We have invested in state-of-the-art equipment to perform active air sampling, as well as compressed gas sampling for microbiological assessment or non-viable particle counting. - [Information Officer](https://qbdgroup.com/en/services/regulatory-affairs/information-officer) A qualified Information Officer from QbD Group can coordinate and monitor pharmaceutical organizations' information management and marketing activities. - [Software Validation, Central IT Systems](https://qbdgroup.com/en/services/software-solutions-services/software-validation) Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. - [Biocompatibility & Biological Evaluation Solutions](https://qbdgroup.com/en/services/toxicology/biocompatibility-biological-evaluation) End-to-end biocompatibility and biological evaluation under ISO 10993, from feasibility and BEP to a submission-ready Biological Evaluation Report. - [Clinical Evidence Support](https://qbdgroup.com/en/services/clinical-solutions/clinical-evidence-support) Our experts support your IVD or CDx with tailored clinical evidence strategies and documentation under IVDR. - [Orphan Diseases](https://qbdgroup.com/en/services/regulatory-affairs/orphan-diseases) Rare diseases deserve just as much attention as more common diseases. We can support you in the development of medicines for patients suffering from rare diseases. - [Software Validation, Central IT Systems](https://qbdgroup.com/en/services/software-solutions-services/software-validation) Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. We specialize in Computer System Validation (CSV) to guarantee that your systems consisten - [R&D Projects](https://qbdgroup.com/en/services/lab-services/rd-projects) QbD Group's Lab Services is uniquely positioned to provide knowledge and customized solutions for the pharma industry. - [Regulatory Intelligence](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-intelligence) Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times. - [Clinical Quality Services](https://qbdgroup.com/en/services/clinical-solutions/clinical-quality-services) Looking for support in setting up your clinical Quality Management System (QMS), revision of Standard Operating Procedures (SOPs) or an audit? QbD Clinical is your experienced partner for all your nee - [RA Strategy for MD & IVD](https://qbdgroup.com/en/services/regulatory-affairs/regulatory-strategy-md-ivd) Our tailored and strategic approach will help guide your organization through the complexities of regulatory frameworks. - [Clinical Expert Services](https://qbdgroup.com/en/services/clinical-solutions/clinical-expert-services) Are you looking for research professionals to support your clinical study under your own management or in an FSP (functional service provider) model? Our expert team of knowledgeable and well-trained - [Experts in Medical Device Clinical Trials](https://qbdgroup.com/en/services/clinical-solutions/medical-device-clinical-trials) Expert support for medical device clinical trials, from strategy to post-market. Explore our services and real-world client success stories. - [RA Design & Development](https://qbdgroup.com/en/services/regulatory-affairs/design-and-development) Embark on your journey by conceptualizing your IVD or MD. We will assist you in navigating the intricate landscape of design and development. - [Post-Market Performance Follow-up (PMPF)](https://qbdgroup.com/en/services/clinical-solutions/pmpf/) Ensure IVDR compliance with our PMPF services. We help confirm the performance and scientific validity of your IVDs through literature reviews, data analysis, and expert reporting. - [Technical Documentation](https://qbdgroup.com/en/services/regulatory-affairs/technical-documentation) We can support the writing and compilation of IVDR/MDR-compliant technical documentation in line with your notified body's specific expectations. - [Notified Body Submissions](https://qbdgroup.com/en/services/regulatory-affairs/notified-body-submissions) Navigating the submission process can be daunting, but you don't have to do it alone. Our experts can prepare and submit your application to the notified body. - [Post-Market Surveillance](https://qbdgroup.com/en/services/regulatory-affairs/post-market-surveillance) Post-Market Surveillance (PMS) is a vital component of maintaining product safety and efficacy once your IVD/Medical Device is on the market. - [Authorised Representative Services](https://qbdgroup.com/en/services/regulatory-affairs/in-country-representative-services) If you want to sell your product in countries other than your own, it is important to consider the local regulations. - [Person Responsible for Regulatory Compliance (PRRC)](https://qbdgroup.com/en/services/regulatory-affairs/person-responsible-for-regulatory-compliance) Are you looking for a person responsible for regulatory compliance (PRRC) for your IVDs or Medical Devices? We provide PRRC services to IVD/MD manufacturers with fewer than 50 employees. - [Authorized Representative (EU-REP)](https://qbdgroup.com/en/services/regulatory-affairs/authorized-representative-eu-rep) QbD Group, supported by the Qarad experts, is an independent partner that can act as your Authorized Representative (EC-REP). - [Authorized Representative (CH-REP)](https://qbdgroup.com/en/services/regulatory-affairs/swiss-authorized-representative) Qarad Suisse S.A. – part of the QbD Group – is an independent partner that can act as your Swiss Authorized Representative (CH-REP). - [UK Responsible Person (UKRP)](https://qbdgroup.com/en/services/regulatory-affairs/ukrp-uk-responsible-person) Qarad UK Ltd. – part of the QbD Group – is an independent partner that can act as your UK Responsible Person (UKRP). - [Linguistic Review](https://qbdgroup.com/en/services/regulatory-affairs/linguistic-review) QbD Group offers expert linguistic review services to meet tight deadlines and regulatory requirements. - [Landing in Europe](https://qbdgroup.com/en/industries/pharma-biotech/landing-in-europe) Accelerate your entry into the European life sciences market with QbD Group's expert regulatory support, compliance solutions, and strategic guidance. - [IVDR Compliance & CE Certification](https://qbdgroup.com/en/services/regulatory-affairs/ivdr-compliance-ce-certification) Strategic IVDR compliance for secure and sustainable EU market access. End-to-end support from regulatory roadmap to CE certification. - [IVDD to IVDR Transition Support](https://qbdgroup.com/en/services/regulatory-affairs/ivdr-transition-support) Get expert support for your IVDD to IVDR transition. From gap assessment to submission, QbD ensures a smooth, compliant path to certification. - [MDR Compliance – CE Certification for Medical Devices](https://qbdgroup.com/en/services/regulatory-affairs/mdr-compliance-ce-certification-for-medical-devices) Achieve EU MDR compliance with QbD Group's expert guidance, ensuring safety, quality, and market access for your medical devices. - [MDD to MDR Transition Support](https://qbdgroup.com/en/services/regulatory-affairs/mdr-transition-support) Need support for your MDD to MDR transition? QbD Group guides you from gap assessment to CE submission. - [Combination Products](https://qbdgroup.com/en/services/regulatory-affairs/combination-products) Navigate the complex regulatory pathways for combination products in the EU and US with QbD Group's expert guidance and tailored support. - [Pharmacovigilance](https://qbdgroup.com/en/services/pharmacovigilance) QbD Group offers a full range of pharmacovigilance services to ensure your products meet compliance standards while safeguarding patient safety. - [Legal Representative](https://qbdgroup.com/en/services/regulatory-affairs/legal-representative) If the sponsor of a performance study is not established in the European Union, we can ensure that a natural or legal person is established in the Union as its legal representative. - [Liaison with Notified Bodies](https://qbdgroup.com/en/services/regulatory-affairs/liaison-with-notified-bodies) Strategic management of Notified Body interactions throughout the conformity assessment process for medical devices and IVDs. - [Vigilance](https://qbdgroup.com/en/services/regulatory-affairs/materiovigilance) Incident monitoring and reporting for medical devices and IVDs - [Coaching & Training](https://qbdgroup.com/en/services/regulatory-affairs/coaching-training) Tailored regulatory training programs to build practical MDR/IVDR competence within your medical device and IVD teams. - [IFUcare](https://qbdgroup.com/en/services/software-solutions-services/ifucare) Discover how our eIFU service can help IVD and medical device manufacturers leave paper IFUs behind, saving costs, simplifying processes, and ensuring regulatory compliance. Developed by regulatory ex - [Scilife™](https://qbdgroup.com/en/services/software-solutions-services/scilife) From document control and training to CAPAs and AI-driven KPIs, Scilife ensures full traceability, integration, and compliance. Its intuitive interface makes it easy to get started, and its powerful f ## Industries Served - [Pharma & Biotech](https://qbdgroup.com/en/industries/pharma-biotech) - [Medical Devices](https://qbdgroup.com/en/industries/medical-devices) - [In Vitro Diagnostics (IVD)](https://qbdgroup.com/en/industries/in-vitro-diagnostics) - [Companion Diagnostics (CDx)](https://qbdgroup.com/en/industries/companion-diagnostics) - [Combination Products](https://qbdgroup.com/en/industries/combination-products) # Recent Content ## Blog Posts - [Why Existing In-House Data Rarely Gets IVD Software Through IVDR](https://qbdgroup.com/en/blog/ivd-software-in-house-data-clinical-performance) — 2026-10-14 · Software Solutions & Services · Pieter Smits & Pieter Bogaert - [The Six Questions an Inspector Will Ask About Your AI](https://qbdgroup.com/en/blog/six-gmp-inspection-questions-ai-governance) — 2026-10-14 · Software Solutions & Services · Elias Muys & Jan Appelmans - [Six Mistakes That Can Impact Your HPV Assay Validation](https://qbdgroup.com/en/blog/hpv-assay-validation-mistakes) — 2026-10-14 · Clinical · Sara Peeters & Davy Vanden Broeck - [Bringing Your US-Authorised AI Diagnostic to Europe: What Transfers and What Doesn't](https://qbdgroup.com/en/blog/fda-to-ivdr-ai-diagnostics-evidence-gap-assessment) — 2026-10-14 · Software Solutions & Services · Pieter Smits & Pieter Bogaert - [One Study, Two Markets: Designing HPV Clinical Performance Studies for IVDR and WHO PQ](https://qbdgroup.com/en/blog/hpv-clinical-performance-studies-ivdr-who-pq) — 2026-10-14 · Clinical · Sara Peeters & Davy Vanden Broeck - [The Meijer Criteria Explained: Why They Matter for Your HPV Assay](https://qbdgroup.com/en/blog/meijer-criteria-hpv-assay-validation-ivdr-who-pq) — 2026-10-14 · Clinical · Sara Peeters & Davy Vanden Broeck - [Six Ways LLMs Can Trip You Up in GMP](https://qbdgroup.com/en/blog/llm-pitfalls-gmp-generative-ai-risks) — 2026-10-14 · Software Solutions & Services · Elias Muys & Jan Appelmans - [Why Annex 1 Implementation Doesn't End at the First CCS Draft](https://qbdgroup.com/en/blog/annex-1-implementation-contamination-control-strategy) — 2026-10-07 · Qualification & Validation · Jo Doucet & Stan Van Kerkhoven - [Regulation (EU) 2025/1466: What Has Changed in Signal Management and Where We Are](https://qbdgroup.com/en/blog/eu-2025-1466-signal-management-eudravigilance) — 2026-10-07 · Vigilance · Almudena del Castillo - [The New EU Variations Guidelines: From New Rules to Better Variations Management](https://qbdgroup.com/en/blog/new-eu-variations-guidelines-variations-management) — 2026-10-07 · Regulatory Affairs · Joanna Rapacz ## Regulatory Updates - [ICH GCP E6 (R3) Annex 2: A Modern Framework for Clinical Trial Innovation](https://qbdgroup.com/en/regulatory-updates/ich-gcp-e6-r3-annex-2-clinical-trial-innovation) — 2026-10-08 · Regulatory Update · QbD Group - [COMBINE Project 2 – Sponsors' Guide on Safety Reporting in Combined Studies](https://qbdgroup.com/en/regulatory-updates/combine-project-2-safety-reporting-combined-studies) — 2026-09-16 · Regulatory Update · Kirsten Van Garsse - [MDCG 2020-16 Rev. 5 – New IVDR Classification Clarifications for QC Controls](https://qbdgroup.com/en/regulatory-updates/mdcg-2020-16-rev5-ivdr-classification-rule-7) — 2026-09-16 · Regulatory Update · Kirsten Van Garsse - [New MDR Updates for Well-Established Technologies](https://qbdgroup.com/en/regulatory-updates/mdr-updates-well-established-technologies-2026) — 2026-07-02 · Regulatory Update · Kirsten Van Garsse - [COMBINE Programme Launches Phase 2 of Coordinated Assessment Pilot](https://qbdgroup.com/en/regulatory-updates/combine-programme-phase-2-coordinated-assessment-pilot) — 2026-06-29 · Regulatory Update · Kirsten Van Garsse - [New Harmonised Standards Under MDR and IVDR](https://qbdgroup.com/en/regulatory-updates/new-harmonised-standards-mdr-ivdr-2026) — 2026-06-23 · Kirsten Van Garsse - [MDCG Publishes Appendix on Transition to EU REP Symbol](https://qbdgroup.com/en/regulatory-updates/mdcg-appendix-transition-eu-rep-symbol-en-iso-15223-1) — 2026-06-23 · Regulatory Update · Kirsten Van Garsse - [MDCG Position Paper on Management of SS(C)P in EUDAMED](https://qbdgroup.com/en/regulatory-updates/mdcg-position-paper-management-sscp-ssp-eudamed) — 2026-06-23 · Regulatory Update · Kirsten Van Garsse - [New Harmonised Standards under MDR and IVDR](https://qbdgroup.com/en/regulatory-updates/new-harmonised-standards-mdr-ivdr) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse - [Updated Manufacturer Incident Report (MIR) Form 7.3.1 Now Mandatory in the EU](https://qbdgroup.com/en/regulatory-updates/updated-manufacturer-incident-report-mir-form-7-3-1-mandatory-eu) — 2026-06-11 · Regulatory Update · Kirsten Van Garsse ## White Papers - [Collaborative Responsibilities in Combined Studies](https://qbdgroup.com/en/whitepapers/collaborative-responsibilities-in-combined-studies) — 2026-09-11 · Regulatory Affairs · Kirsten Van Garsse - [Designing Orthopaedic Clinical Evidence for Europe](https://qbdgroup.com/en/whitepapers/designing-orthopaedic-clinical-evidence-europe) — 2026-09-04 · Clinical · Laura Drikite & Caroline Aernouts - [First-In-Human Readiness Guide for Early-stage Biotechs](https://qbdgroup.com/en/whitepapers/first-in-human-readiness-guide-early-stage-biotechs) — 2026-08-12 · Regulatory Affairs · Angeles Escartí-Nebot - [Extractables & Leachables in Pharma](https://qbdgroup.com/en/whitepapers/extractables-leachables-pharma-ich-q3e) — 2026-08-06 · Quality Assurance · Javier López - [Leveraging AI to Streamline SAE and SUSAR Management in Clinical Trials](https://qbdgroup.com/en/whitepapers/ai-sae-susar-management-clinical-trials) — 2026-07-08 · Clinical · Anam Ahmad - [A Complete Roadmap for US Biotechs Entering the EU/UK Market](https://qbdgroup.com/en/whitepapers/roadmap-us-biotechs-eu-uk-market) — 2026-06-08 · Regulatory Affairs · Angeles Escartí-Nebot - [Innovations in ATMP: State of the Art in 2026](https://qbdgroup.com/en/whitepapers/innovations-in-atmp-state-of-the-art-2026) — 2026-06-03 · Regulatory Affairs · QbD Group - [Scaling Pharmacovigilance in Europe](https://qbdgroup.com/en/whitepapers/scaling-pharmacovigilance-europe) — 2026-05-21 · Pharmacovigilance · Almudena del Castillo, Division Head Vigilance - [Home Market Approval ≠ EU Readiness](https://qbdgroup.com/en/whitepapers/home-market-approval-eu-readiness) — 2026-04-15 · Regulatory Affairs · Petra De Geest & Anne-Sophie Grell - [Sponsor Responsibilities in IVD Clinical Performance Studies](https://qbdgroup.com/en/whitepapers/sponsor-responsibilities-ivd-performance-studies) — 2026-03-30 · Clinical · Annelies Rotthier & Kirsten Van Garsse ## Checklists - [ISO 13485:2016 - Compliance Checklist](https://qbdgroup.com/en/downloads/checklists/checklist-iso-134852016) — 2025-04-17 - [Medical Device Regulation (MDR) Checklist](https://qbdgroup.com/en/downloads/checklists/mdr-checklist) — 2025-02-26 - [21 CFR Part 11 Checklist and Questionnaire](https://qbdgroup.com/en/downloads/checklists/21-cfr-part-11-checklist-and-questionnaire) — 2024-10-15 - [EudraLex Volume 4 Annex 11 Compliance Checklist](https://qbdgroup.com/en/downloads/checklists/eudralex-volume-4-annex-11-compliance-checklist) — 2024-09-17 ## Case Studies - [One Integrated HPV Study for IVDR and WHO Prequalification](https://qbdgroup.com/en/case-studies/integrated-hpv-study-ivdr-who-prequalification) — 2026-10-07 · Case Study · QbD Group - [Landing in Europe: Techdow's EU Market Entry](https://qbdgroup.com/en/case-studies/techdow-eu-market-entry) — 2026-07-22 - [Landing in Europe: Henlius's EU Market Entry](https://qbdgroup.com/en/case-studies/henlius-eu-market-entry) — 2026-06-03 - [Scaling a Global Pharmacovigilance Model for International Growth](https://qbdgroup.com/en/case-studies/scalable-pharmacovigilance-model-global-growth) — 2026-05-06 - [Building a Global Pharmacovigilance Framework for Seamless EU Entry and Worldwide Expansion](https://qbdgroup.com/en/case-studies/global-pharmacovigilance-framework-eu-expansion) — 2026-05-06 - [GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software](https://qbdgroup.com/en/case-studies/gmp-support-for-closing-capas-across-qa-qualval-and-software) — 2026-02-03 - [Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access](https://qbdgroup.com/en/case-studies/multiplex-respiratory-antigen-test-accelerating-ivdr-market-access) — 2025-08-19 - [Agile Validation Support for a Global Life Sciences Organization](https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization) — 2025-08-06 - [Building a Unified QMS for a Non-Profit Lab Organization](https://qbdgroup.com/en/case-studies/building-a-unified-qms-for-a-non-profit-lab-organization) — 2025-08-06 - [Faster Market Entry Through Integrated IVDR and WHO Strategy](https://qbdgroup.com/en/case-studies/faster-market-entry-through-integrated-ivdr-and-who-strategy) — 2025-08-05 ## Webinars - [Estrategia de Control de Contaminación (CCS): cómo alinear QC, QA y Regulatory ante una inspección](https://qbdgroup.com/en/webinars/ccs-qc-qa-regulatory-control-contaminacion-anexo-1-on-demand) — 2026-10-16 · Quality Assurance · Rodrigo Mondelo Ripoll - [Fund It, Build It, Certify It: A MedTech Startup's Roadmap to Market](https://qbdgroup.com/en/webinars/medtech-startup-roadmap-to-market) — 2026-10-14 · Regulatory Affairs - [Wellness App vs. Medical Device: Which Side Are You Really On?](https://qbdgroup.com/en/webinars/wellness-app-vs-medical-device-on-demand) — 2026-10-14 · Software Solutions & Services - [From Pilot to Practice: Signal Management Under Regulation (EU) 2025/1466](https://qbdgroup.com/en/webinars/signal-management-regulation-eu-2025-1466) — 2026-10-07 · Pharmacovigilance · QbD Group - [Optimizing Variations Management Under the New EU Guideline](https://qbdgroup.com/en/webinars/optimizing-variations-management-new-eu-guideline) — 2026-10-06 · Regulatory Affairs · QbD Group - [¿Implementando un sistema en la nube? Ventajas y desventajas para el cumplimiento BPx](https://qbdgroup.com/en/webinars/sistemas-en-la-nube-bpx-ventajas-riesgos) — 2026-10-01 · Software Solutions & Services · Enrique Alfonso Cruz Barrera - [CE Mark Won't Pay Your Bills. Reimbursement Will.](https://qbdgroup.com/en/webinars/ce-mark-wont-pay-your-bills-reimbursement-will) — 2026-09-30 · Regulatory Affairs · Anne-Sophie Grell & Marco Kalms - [The Emergency Room Reality of Neurology Device Trials: A Planning Guide for Sponsors, Through the Eyes of the Sites Running Their Studies](https://qbdgroup.com/en/webinars/emergency-room-reality-neurology-device-trials) — 2026-09-30 · Clinical Solutions · Sophie Achten - [The Future of Medical Information](https://qbdgroup.com/en/webinars/the-future-of-medical-information-on-demand) — 2026-09-25 · Pharmacovigilance - [IVDR & WHO Requirements for Clinical Performance: With a focus on HPV studies](https://qbdgroup.com/en/webinars/ivdr-who-requirements-hpv-studies-on-demand) — 2026-09-22 · Clinical ## Company News - [QbD Group celebrates 10 years in Spain with a look at the future of Life Sciences](https://qbdgroup.com/en/news/qbd-group-10-years-spain) — 2026-10-09 · Corporate News · QbD Group - [Rescop's e-VLM validation software rebrands as VLMcare](https://qbdgroup.com/en/news/rescops-e-vlm-rebrands-as-vlmcare) — 2026-07-01 · Company News · QbD Group - [QbD Group awarded Platinum label as Best Managed Company 2026](https://qbdgroup.com/en/news/qbd-group-awarded-platinum-label-as-best-managed-company-2026) — 2026-05-29 · Award · QbD Group - [QbD Group and Vigintake Partner to Drive the Digital Transformation of Pharmacovigilance](https://qbdgroup.com/en/news/qbd-group-vigintake-partner-digital-transformation-safety-processes) — 2026-05-13 · Partnerships · QbD Group - [QbD Group acquires Rescop, expanding its Software Solutions & Services division and strengthening its presence in the Netherlands, Poland, G](https://qbdgroup.com/en/news/qbd-group-acquires-rescop-expanding-software-solutions-services-division) — 2026-05-12 · Acquisition · QbD Group - [QbD Group wins AEFI Award for Best Publication of 2025 for its article on pharmacovigilance in innovative therapies](https://qbdgroup.com/en/news/qbd-group-wins-aefi-award-best-publication-2025) — 2026-05-05 · Award · QbD Group - [QbD Group and delaware strengthen partnership to accelerate digitalization in life sciences](https://qbdgroup.com/en/news/qbd-group-and-delaware-strengthen-partnership) — 2025-11-27 · Partnership · QbD Group - [QbD Group Joins ASEBIO: A strategic Step in Our Commitment to Scientific Excellence](https://qbdgroup.com/en/news/qbd-group-joins-asebio) — 2025-11-12 · Company · QbD Group - [QbD Group recognized as Best Pharmacovigilance Service Company at Farmaforum 2025](https://qbdgroup.com/en/news/qbd-group-recognized-as-best-pharmacovigilance-service-company-at-farmaforum-2025) — 2025-09-19 · Award · QbD Group - [QbD Group welcomes Dr. Diane Fairweather as Division Head Clinical](https://qbdgroup.com/en/news/qbd-group-welcomes-diane-fairweather-as-division-head-clinical) — 2025-05-27 · People · QbD Group ## Events - [World Patient Safety Congress Europe](https://qbdgroup.com/en/events/world-patient-safety-congress-europe-2026) — 2026-08-07 - [MEDICA 2026](https://qbdgroup.com/en/events/medica-2026) — 2026-07-22 · Medical Devices · QbD Group - [CPHI Milan 2026](https://qbdgroup.com/en/events/cphi-milan-2026) — 2026-07-02 · Pharma & Biotech · QbD Group - [Farmaforum 2026](https://qbdgroup.com/en/events/farmaforum-2026) — 2026-07-01 · Pharma & Biotech - [Symposium AEFI 2026](https://qbdgroup.com/en/events/symposium-aefi-2026) — 2026-04-16 · Quality Assurance - [2nd Annual Outsourcing in Clinical Trials: Medical Devices USA 2026](https://qbdgroup.com/en/events/outsourcing-clinical-trials-medical-devices-usa-2026) — 2026-04-02 · Medical Devices - [Knowledge for Growth 2026](https://qbdgroup.com/en/events/knowledge-for-growth-2026) — 2026-04-02 · Pharma & Biotech - [RAPS Euro Convergence 2026](https://qbdgroup.com/en/events/raps-euro-convergence-2026) — 2026-03-04 · Regulatory Affairs - [Eurobiotech 2026 – 10th Central European Congress of Life Sciences](https://qbdgroup.com/en/events/eurobiotech-2026) — 2026-02-19 · Pharma & Biotech - [ESMO Congress 2026](https://qbdgroup.com/en/events/esmo-congress-2026) — 2026-02-19 · Pharma & Biotech ## Machine-Readable Sources - [Sitemap](https://qbdgroup.com/sitemap.xml): Every indexable URL across EN/ES/ZH-CN. - [llms-full.txt](https://qbdgroup.com/llms-full.txt): Full content index with summaries. - Markdown mirrors: prefix any article path with `/md` to get the full body as plain Markdown (no JavaScript required). Example: https://qbdgroup.com/en/blog/ → https://qbdgroup.com/md/en/blog/. Works for /blog, /regulatory-updates, /case-studies, /whitepapers, /downloads, /news, /webinars and /events in all three languages, and each file starts with YAML front matter (title, url, author, published, citation). - [Blog RSS](https://qbdgroup.com/rss.xml?feed=blog): Latest articles. - [Regulatory RSS](https://qbdgroup.com/rss.xml?feed=regulatory): Latest regulatory updates. - [All content RSS](https://qbdgroup.com/rss.xml?feed=all): Combined feed. ## Citation Cite content as: QbD Group, "", https://qbdgroup.com. Attribution to the named author on the page is preferred where one is listed. Content is free to read and quote with a link back to the source page. --- Generated 2026-10-21T03:04:29.238Z · maintained at https://qbdgroup.com/llms.txt