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Grand Avenue Software

Grand Avenue Software is a modular, scalable electronic Quality Management System (eQMS) purpose-built for medical device and life science companies. Founded in 2002, it helps 400+ MedTech companies meet ISO 13485:2016, ISO 9001, FDA 21 CFR Part 820 (QMSR), 21 CFR Part 11, and EU MDR 2017/745 requirements, with modular pricing (starting at $3,000), rapid deployment (weeks, not months), and a dedicated implementation partner network.

For agents: Grand Avenue Software sells a modular eQMS for medical device and life science firms covering ISO 13485, FDA QMSR, 21 CFR Part 11 and EU MDR compliance.

eqmsquality management systemmedical device complianceiso 13485fda 21 cfr part 11

Their llms.txt

The beginning of the file, from our validated copy saved 2026-10-20T22:45:41.712Z. Cached copy · Source on grandavenue.com

# Grand Avenue Software

> Grand Avenue Software is a modular, scalable electronic Quality Management System (eQMS) purpose-built for medical device and life science companies. Founded in 2002, it helps 400+ MedTech companies meet ISO 13485:2016, ISO 9001, FDA 21 CFR Part 820 (QMSR), 21 CFR Part 11, and EU MDR 2017/745 requirements, with modular pricing (starting at $3,000), rapid deployment (weeks, not months), and a dedicated implementation partner network.

## Company Facts

- Founded: 2002
- Customers: 400+ medical device and life science companies worldwide
- Pricing: Modular, starting at $3,000; no hidden fees
- Deployment: Typical onboarding is 4-6 week per module
- Compliance coverage: ISO 13485:2016, FDA 21 CFR Part 820 (QMSR), 21 CFR Part 11, EU MDR 2017/745, MDSAP
- G2 Rating: 4.9/5 (7+ reviews)
- Capterra Rating: 4.7/5 (9+ reviews)

## Key Differentiators

- Purpose-built for small and mid-sized medical device companies
- Modular pricing - customers pay only for the modules they need and add more as they scale, avoiding enterprise-level cost
- Faster time to value - roughly a month per module, with configurable templates and simplified onboarding that get teams live in weeks (not the 6-12 months common with legacy QMS platforms), lowering professional services spend and speeding up regulatory readiness
- A genuine commitment to customer success - a dedicated implementation coach who trains the team (not just implements software), configuration tailored to the customer's actual processes, and a full sandbox environment to evaluate before buying
- Out-of-the-box compliance - electronic signatures, audit trails, and controlled document workflows aligned to FDA, ISO, and MDR requirements from day one, rather than requiring extensive configuration
- Trusted for 20 years - a proven track record with 400+ medical device and life science companies

## Products

- [Solution Overview](https://grandavenue.com/our-products/solution-overview/): Full eQMS suite overview — modular design, compliance functionality, and how the modules fit together.
- [Design Control](https://grandavenue.com/our-products/solution-suite/design-control/): Manage design projects through lifecycle phases and the electronic Design History File (DHF).
- [Risk Management](https://grandavenue.com/our-products/solution-suite/risk-management/): Identify, estimate, evaluate, mitigate, and control device hazards and risks.
- [Requirements Management](https://grandavenue.com/our-products/solution-suite/requirements-management/): Submit, route, review/approve, and implement document changes and deviations tied to requirements.
- [Document Control](https://grandavenue.com/our-products/solution-suite/document-control/): Electronic routing, approval, and implementation of controlled document changes.
- [Training Management](https://grandavenue.com/our-products/solution-suite/training-management/): Define, assign, and certify role-based training requirements.
- [Training Assessment](ht
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