Trusted by medical device innovators.

Akina, a startup focusing on physiotherapy, passed their MDR QMS audit only 6 months after starting with Formwork.

“OpenRegulatory’s Formwork offers distinct advantages to startups embarking on their regulatory compliance journey. With its dual functionality encompassing both Quality Management System (QMS) and Technical Documentation capabilities, it has provided us with a holistic solution that streamlines our quality processes while enhancing the management of our technical documentation.

One key aspect that stands out is the simplicity and user-friendliness of the interface and the added convenience of pre-built templates and a wizard tool, complemented by instructive tutorial videos, which supported us in establishing an ISO 13485 compliant and certified QMS. Another standout aspect of OpenRegulatory is their exceptional customer support. The team consistently demonstrates a commitment to addressing our inquiries promptly and providing assistance as needed. Their dedication to ensuring our satisfaction is truly commendable and makes us feel valued as customers.

In conclusion, OpenRegulatory has proven to be an invaluable partner for startups embarking on their regulatory compliance journey.”

Noah Labs got their connected-care platform for cardiology certified as an MDR Class IIa device.

“With Formwork, we successfully set up our quality management system and also used it to create the technical documentation for our class IIa medical device. We were particularly helped by the numerous explanatory videos and the easily usable templates.”

Prof. Darrel Francis, Professor of Cardiology at Imperial College London, is a huge fan of Formwork too.

“OpenRegulatory was the ONLY site that had anything actually USEFUL on it. Every other site was just companies saying how brilliant their software is, but (as Oliver points out) mysteriously no actual screenshots.

Then we thought “Free stuff! That’s amazing! Let’s get it and try and do it ourselves.”

Then we read it and said, “Hang on, this regulatory stuff is actually quite straightforward when someone who actually DEVELOPS stuff, is explaining it to you, because they don’t make up bullshit terms to confuse you.”

Then we said, “OK how much is the paid version?”

And we worked out that we didn’t actually need the paid version yet, but wanted to give something back to the company, signed up for it. The meetings with Oliver were absolutely brilliant. He cut through complex questions like a knife through butter.

Amazing. And he gave lots of excellent free advice.”

Kristina Stepanic, a software developer at A.I. VALI, used Formwork to pass their Health Canada audit with zero findings.

“As a startup that initially managed our QMS entirely in Google Drive, we realized how difficult and unsustainable that approach was. After researching various eQMS options, we were beyond grateful to discover OpenRegulatory’s Formwork. There’s truly nothing else like it.

We value simplicity, transparency and ease-of-use (what good is an eQMS that no one on the team wants to use?). Formwork checked all these boxes and more. With my background in software development before transitioning into quality and regulatory affairs, I, along with our entire dev team, can genuinely appreciate an intuitive system that is not overengineered. It relieved all our headaches.

I also cannot say enough good things about the team at OpenRegulatory. I offered some feedback and they acted on it right away. This is simply a team I trust.

Ultimately, we were able to pass our ISO 13485 audit with zero findings, and there’s no doubt that Formwork played a key role in making that possible — quickly and painlessly.”