# 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](https://grandavenue.com/our-products/solution-suite/training-assessment/): Quiz-based testing that extends Training Management to verify comprehension. - [Audit Management](https://grandavenue.com/our-products/solution-suite/audit-management/): Plan and manage internal, supplier, and external audits, findings, and resolutions. - [CAPA](https://grandavenue.com/our-products/solution-suite/capa/): Corrective and preventive action management with root-cause analysis and verification of effectiveness. - [Complaint Handling](https://grandavenue.com/our-products/solution-suite/complaint-handling/): Capture, investigate, trend, and report product or service complaints. - [Nonconforming Materials](https://grandavenue.com/our-products/solution-suite/nonconforming-materials/): Identify, quarantine, disposition, and trend nonconforming products. - [Equipment Management](https://grandavenue.com/our-products/solution-suite/equipment-management/): Track equipment calibration, maintenance, qualification, and unplanned events. - [Supplier Management](https://grandavenue.com/our-products/solution-suite/supplier-management/): Approve and manage suppliers, the Approved Supplier List (ASL), and supplier controls. - [Connector](https://grandavenue.com/our-products/solution-suite/connector/): Standards-based API integration between Grand Avenue Software and other business systems. - [Authentication Management](https://grandavenue.com/our-products/solution-suite/authentication-management/): Single sign-on (SSO) support for Grand Avenue Software. ## Implementation & Pricing - [Implementation & Support](https://grandavenue.com/implementation/): Onboarding process, timelines (typically 4-6 weeks), validation support, and ongoing customer success model. - [Find a Partner](https://grandavenue.com/implementation/find-a-partner/): Directory of implementation partners who deploy and configure Grand Avenue Software. - [Pricing](https://grandavenue.com/pricing/): Modular eQMS pricing starting at $3,000, who each tier fits, and what's included. - [Request a Demo](https://grandavenue.com/get-a-demo/): Schedule a product walkthrough with the Grand Avenue Software team. ## Company - [About Us](https://grandavenue.com/company/): Company history, mission, and leadership team bios. - [Customer Reviews](https://grandavenue.com/reviews/): Verified customer ratings and testimonials from medical device companies. - [Case Studies](https://grandavenue.com/case-studies/): Written case studies detailing customer implementations and outcomes across MedTech companies of varying size. - [Contact Us](https://grandavenue.com/contact-us/): Contact information and inquiry form. ## Resources - [Resource Library](https://grandavenue.com/resources/): Guides, reports, webinars, and articles on eQMS adoption, compliance, and quality operations. - [MedTech QMS Glossary](https://grandavenue.com/resources/medtech-qms-glossary/): Definitions of quality management and regulatory compliance terms used in medical device manufacturing. - [Blog](https://grandavenue.com/blog/): Articles on quality management, regulatory compliance, and MedTech industry trends. - [Training Calendar](https://grandavenue.com/training/): Schedule of live training sessions for configuring and using Grand Avenue Software.