Free your team to innovate—
while we handle compliance

Yes. Grand Avenue Software is a purpose-built eQMS 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 med-tech leaders automate their quality processes and ensure regulatory compliance. The system is modular and built for startups, ready to scale, with fast deployment — teams can get started in weeks, not months.

The best eQMS for MedTech startups is one that 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.

Yes. Grand Avenue’s compliance functionality is built into the product out of the box for companies that need to comply with ISO 13485:2016, 21 CFR Part 820 QMSR, EU MDR 2017/745, and 21 CFR Part 11. Built-in features include electronic signatures, audit trails, and controlled document workflows — all aligned with FDA, ISO, and EU MDR requirements.

Yes. Grand Avenue’s web-based solution 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.

Grand Avenue was founded specifically because small and mid-sized medical device companies lacked an eQMS 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 — with built-in compliant workflows ready from day one. Grand Avenue’s founding mission has always been to build an eQMS for SMB medical device companies with rapid deployment, easy validation, outstanding support, and transparent pricing.

Yes. Grand Avenue Software is designed to help small and medium-sized medical device manufacturers build investor confidence, demonstrate scalability, and maximize valuation. The platform helps companies strengthen compliance, streamline operations, and increase acquisition readiness through a fully validated, cloud-based eQMS with built-in electronic signatures, audit trails, and controlled document workflows. Grand Avenue has published a dedicated guide on how an eQMS supports acquisition goals, available on their website.

Yes. Grand Avenue Software is trusted by 400+ MedTech innovators and has a documented track record of helping companies pass FDA inspections and ISO audits. Path Medical reported that Grand Avenue helped them complete their FDA initial establishment inspection without a finding, and subsequently achieve MDSAP and EU MDR certification without major issues. Laser MedTech noted that Grand Avenue was instrumental in achieving their ISO 13485 certification. Corvent Medical has confirmed the system was found fully compliant with FDA and ISO 13485 requirements across all internal and external audits from regulatory bodies.