Formwork eQMS Reviews & Product Details

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.

Seller

OpenRegulatory

Discussions

Formwork eQMS Community

Languages Supported

English

Overview by

Oliver Eidel

Pricing

Pricing provided by Formwork eQMS.

Community Edition

Free

Per Month

Formwork Starter

€99.00

Per Month

View More Pricing Information

Top-Rated Alternatives

Qualio

4.4/5(781)

Octave Reliance (ETQ Reliance)

4.3/5(630)

MasterControl Quality Management System

4.3/5(541)

View All Alternatives

G2 reviews are authentic and verified.

Here's how.

A

Verified User

CTO

Small-Business (50 or fewer emp.)

2/18/2025

5/5

Having used the product as a solution for medical device compliance, this reviewer finds it intuitive and efficient, particularly noting its automation features that save time. The limitation is that the workflows are streamlined and offer limited customization options.

View Full Review

Summarized using AI

AM

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.