Formwork eQMS Reviews 2026: Details, Pricing, & Features

C H.

CTO

Small-Business (50 or fewer emp.)

2/18/2025

"Amazing eQMS"

5/5

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! Review collected by and hosted on G2.com.

What do you dislike about Formwork eQMS?

Workflows are _very_ streamlined and cannot be customzed a lot. Review collected by and hosted on G2.com.

Andreea M.

Small-Business (50 or fewer emp.)

2/12/2025

"I highly recommend Formwork"

5/5

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. Review collected by and hosted on G2.com.

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! Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.