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SimpliMedica: Quality and Regulatory Consultancy for Medical Devices

Medical device regulatory consultancy services designed to help you manage the challenges of compliance and bring your products to market efficiently\.

Their llms.txt

The beginning of the file, from our validated copy saved 2026-10-24T08:42:28.931Z. Cached copy · Source on simplimedica.com

# SimpliMedica: Quality and Regulatory Consultancy for Medical Devices

> Medical device regulatory consultancy services designed to help you manage the challenges of compliance and bring your products to market efficiently\.

Generated by Yoast SEO v28.7, this is an llms.txt file, meant for consumption by LLMs.

## Pages
- [Quality Management for Medical Devices](https://simplimedica.com/medical-device-training-courses/quality-management-for-medical-devices/)
- [Intended Use Statement](https://simplimedica.com/intended-use-statement/)
- [Med\-Tech Start\-Ups](https://simplimedica.com/med-tech-start-ups/)
- [Contact](https://simplimedica.com/contact/)
- [Home](https://simplimedica.com/)

## Posts
- [Med\-Tech Start\-Up Networking Morning](https://simplimedica.com/med-tech-networking-morning-2026/)
- [January 2025 \- Medical Devices Regulatory Insights](https://simplimedica.com/january-2025-medical-devices-regulatory-insights/)

## Products
- [Software as Medical Device Start\-Up Template Package](https://simplimedica.com/product/software-as-medical-device-start-up-template-package/): \<p class="p1" style="text\-align: justify;"\>\<span class="s1"\>If you are a start\-up company developing an app or health software that could have an intended medical purpose, then you will need to consider the adoption of the recognized standard for Medical Device Software EN 62304: 2006\+A1: 2015\. The standard guides you to output a number of documents that can be used as Verification and Validation of the software in preparation for submission to the notified bodies or the FDA etc\.\</span\>\</p\>
\<p class="p1" style="text\-align: justify;"\>\<span class="s1"\>Pharmi Med has prepared these templates to help start\-up companies who traditionally do not have Medical Device experience but usually from a Software Engineering background but need to penetrate the market\. We have reduced the burden by creating these templates for your engineers\. If you need further assistance in the regulatory framework of submissions please contact us here\</span\>\</p\>
\<p style="text\-align: left;"\>You can preview the document below:\</p\>
\<p style="text\-align: left;"\>\[real3dflipbook id='45'\]\</p\>
\<p style="text\-align: left;"\>You may purchase the full package including instructions for use below\.\</p\>
- [Liquid Filler IOQ](https://simplimedica.com/product/liquid-filler-ioq/): The Liquid Filler IOQ template is a versatile template for filling lines, and without a vision system\.

A preview of the the IOQ for Validation Protocol is available here:

\[real3dflipbook id='35'\]

You may purchase the full 27 page document in convenient Microsoft Word format including instructions for use below\.
- [Capper IOQ Template](https://simplimedica.com/product/capper-ioq-template/): The Capper IOQ template is a versatile template for all capping machines, and without a vision system\.

A preview of the the IOQ for Validation Protocol is available here:

\[real3dflipb
…

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