# Formwork eQMS Reviews **Vendor:** OpenRegulatory **Category:** [Medical Quality Management Systems (QMS)](https://www.g2.com/categories/medical-qms) **Average Rating:** 5.0/5.0 **Total Reviews:** 2 ## About Formwork eQMS OpenRegulatory is a medical device consultancy and SaaS provider headquartered in Berlin, Germany. It helps companies achieve compliance with the EU MDR and US FDA. In addition to consulting, OpenRegulatory offers Formwork, an eQMS software targeted towards agile, founder-led companies. Formwork is one of the most popular choices for eQMS software among medical device startups due to its unlimited user seats (no per-seat pricing), monthly billing (no commitments) and easy data export in case customers want to migrate to another provider. ## Formwork eQMS Pros & Cons **What users like:** - Users commend Formwork's **streamlined audit management** , enhancing efficiency and confidence in compliance processes. (1 reviews) - Users value the **automation features** of Formwork, which significantly enhance compliance documentation and save time. (1 reviews) - Users value the **seamless collaboration** with Formwork, enhancing efficiency and compliance while managing complex processes effortlessly. (1 reviews) - Users value the **exceptional customer support** of Formwork, enhancing their experience with efficient and effective guidance. (1 reviews) - Users value the **customization options** in Formwork, enhancing their compliance processes and overall efficiency. (1 reviews) - Document Control (1 reviews) - Efficiency Improvement (1 reviews) - Features (1 reviews) - Implementation Ease (1 reviews) - Improvement (1 reviews) **What users dislike:** - Users find the **inefficient workflow** of Formwork eQMS limits flexibility and customization options for their needs. (1 reviews) - Users find the **limited customization** of Formwork eQMS restricts their ability to tailor workflows effectively. (1 reviews) ## Formwork eQMS Reviews ### 1. Amazing eQMS **Rating:** 5.0/5.0 stars **Reviewed by:** C H. | CTO, Small-Business (50 or fewer emp.) **Reviewed Date:** February 18, 2025 **What do you like best about Formwork eQMS?** 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! **What do you dislike about Formwork eQMS?** Workflows are _very_ streamlined and cannot be customzed a lot. **What problems is Formwork eQMS solving and how is that benefiting you?** Taking a lean approach to eQMS ### 2. I highly recommend Formwork **Rating:** 5.0/5.0 stars **Reviewed by:** Andreea M. | Small-Business (50 or fewer emp.) **Reviewed Date:** February 12, 2025 **What do you like best about Formwork eQMS?** 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. **What do you dislike about Formwork eQMS?** So far, our experience with Formwork has been excellent, and we haven’t encountered any major drawbacks. If anything, we’d love to see even more features added over time to further enhance its capabilities! **What problems is Formwork eQMS solving and how is that benefiting you?** We have been using OpenRegulatory’s eQMS software, Formwork, for some time now, and it has been an excellent solution for managing our quality processes. 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. Our favorite feature is the Risk Management module, which has significantly improved how we track, update, and define risks, making the process much more structured and transparent. The system also integrates seamlessly with various essential modules, including: Document and record control, CAPA (Corrective and Preventive Actions) management, training module, software requirements and test management, usability engineering management. For startups, Formwork is an especially valuable solution, as it provides a structured yet flexible approach to compliance without unnecessary complexity. Additionally, its automation features help save time and ensure consistency across all documents. Overall, Formwork has been a game-changer for our quality and regulatory processes, and we highly recommend it to any organization looking for an efficient, user-friendly eQMS. - [View Formwork eQMS pricing details and edition comparison](https://www.g2.com/products/formwork-eqms/reviews?section=pricing&secure%5Bexpires_at%5D=2026-05-14+12%3A29%3A57+-0500&secure%5Bsession_id%5D=25cc8cbf-1e27-4124-b005-d532476376d8&secure%5Btoken%5D=b495f8a357ba88b021186370dc35f5533f8418a88bed8364fe3c271b45c61b01&format=llm_user) ## Formwork eQMS Features **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes ## Top Formwork eQMS Alternatives - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (730 reviews) - [Octave Reliance (ETQ Reliance)](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) - 4.3/5.0 (595 reviews) - [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) - 4.3/5.0 (504 reviews)