We’ve been extremely satisfied with Formwork as our eQMS solution for medical devices. As a startup navigating the complexities of EU MDR compliance, we needed a system that is intuitive, efficient, and cost-effective—and Formwork has exceeded our expectations. One of its biggest strengths is its streamlined workflows for document control, CAPAs, risk management, and audit preparation. The automation features have been a game-changer, saving us countless hours by simplifying compliance documentation and ensuring consistency across our processes. Another standout feature is its fixed-fee pricing and unlimited user seats, making it an ideal choice for growing startups. Unlike other eQMS providers that charge per user or document, Formwork allows our team to collaborate seamlessly without worrying about additional costs. We also appreciate how well it integrates with our development processes, particularly in managing software requirements, test cases, and usability engineering. Having everything centralized in one system has significantly improved our efficiency and compliance readiness. Thanks to Formwork, we successfully navigated our MDR audit with confidence. If you’re a medical device startup looking for an affordable, powerful, and audit-ready eQMS, we highly recommend giving Formwork a try!

One of its biggest strengths is the ability to handle both QMS data and technical documentation in one centralized platform, which has streamlined our workflow and made compliance management much more efficient.