From Zero To Successful Audit.
In 6 Months.
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."

Isabella Bauer
Quality & Regulatory Affairs Manager at Akina Ltd
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.”

Oliver Weiss
Founder & CEO at Noah Labs
And 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 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."

Prof. Darrel Francis
Professor of Cardiology at National Heart and Lung Institute, Imperial College London
And not just that! We have more than 2000 companies using Formwork. Here are some of our favorite customers:










Ready To Get Started?
Click the button to create your Formwork company account and start your free trial of Formwork QMS + Techdoc right away, no credit card required. You can continue to use the free version after your trial.
Got Questions?
Reach out any time, we're happy to help!