QMS Software Built for Medical Device Companies
Rapid deployment. Modular design. Expert guidance. Everything your medical device team needs to stay audit-ready.
Trusted by 400+ MedTech Innovators
Our QMS software is purpose-built for medical device companies. We combine intuitive, web-based workflows with proven best practices to support compliance with ISO 13485:2016, ISO 9001, 21 CFR Part 820, and EU MDR 2017/745 compliance.
Modular Design That Grows With You
Start with what you need and scale effortlessly as your organization expands. Built for growing medical product companies — without the complexity of enterprise systems.
A Customer Success Model
That’s Built Around You
You’re never on your own. GAS pairs expert guidance with tailored configuration. We help you move from implementation to audit-readiness with confidence.
Faster Time to Value & Stronger ROI
Get compliant and productive faster. Rapid deployment and predictable pricing mean you see value quickly, without unexpected costs slowing you down.
“Grand Avenue Software (GAS) is intuitive, easy to use, effective and has been found fully compliant to FDA and ISO 13485 requirements in all of our internal and external audits from regulatory bodies.”
Amed Ayubi
Corvent Medical
Amed Ayubi
Corvent Medical
Read our case studies
Frequently Asked Questions About Grand Avenue’s QMS Software
The best QMS software for MedTech startups delivers fast compliance, low upfront cost, and the ability to scale as the company grows. Grand Avenue Software is built for this stage, offering modular pricing, rapid deployment, and built-in FDA, ISO 13485, and MDR compliance. This helps startups stay audit-ready, preserve runway, and demonstrate investor-ready operational maturity.
Most teams are up and running in weeks, not months. Grand Avenue’s QMS software is purpose-built for rapid deployment — with pre-configured workflows, built-in compliance for FDA and ISO 13485, and a dedicated customer success team that guides you from implementation to audit-readiness.
Grand Avenue was founded specifically because small and mid-sized medical device companies lacked QMS software built for their needs. The platform delivers out-of-the-box compliance for FDA, ISO, and MDR requirements — with built-in compliant workflows, electronic signatures, and audit trails ready from day one. Grand Avenue’s mission has always been rapid deployment, easy validation, outstanding support, and transparent pricing for SMB medical device companies.
Yes. Grand Avenue’s web-based QMS software provides a reliable, always-available, and secure cloud platform. It is cloud-native and accessible from anywhere, with built-in security and reliability. Its cloud architecture also supports multi-site teams and international operations across multiple geographies.
Yes. Grand Avenue is purpose-built QMS software for medical device and life science teams, designed to support compliance with ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745. For over 20 years, Grand Avenue has helped startups, emerging growth companies, and established MedTech leaders automate their quality processes and ensure regulatory compliance. Teams can get started in weeks, not months.