Welcome to the Formwork Manual! And thanks for dropping by :)
Formwork is an eQMS software which startups love to get their medical device compliance done. I started building Formwork back in 2020 after my first job at a medical device software startup, after which I noticed that medical device compliance and especially eQMS software to achieve medical device compliance was entirely broken. You had consultants selling crappy word templates for thousands of euros, and you had eQMS software companies charging five-figure sums for software which looked like it had been written 20 years ago.
OpenRegulatory was and is my attempt to change that. We started out by offering free EU MDR medical device compliance templates, and later started offering a lean, affordable eQMS software, which was targeted towards startups and other founder-led fast-paced companies.
That software became Formwork.
And now in the meantime, a few years later, Formwork has enabled thousands of companies to get their medical device documentation done - with great success, too, as it has passed multiple EU MDR, FDA and Health Canada audits.
While we are OpenRegulatory could have done what most successful startups do - selling the company, or raising prices, or both - we decided to "screw that" and stay true to our mission of supporting startups and enabling small companies to enter the very broken medical device market.
That's why Formwork is still priced extremely affordably. Our pricing is transparent, it's on our website and there are no custom deals and no negotiated discounts. You see what you get. And countless startups have voted with their wallets and decided to trust Formwork with their medical device documentation.
Talking about trust - OpenRegulatory is profitable, 100% founder-owned (by me!) and therefore, arguably, a safer and more sustainable choice than many of our competitors who are funded by venture capital investors which means they are usually not profitable and at risk of getting sold to other companies in the future with very uncertain outcomes, e.g. raising prices or locking in customers by not allowing easy data exports.
Formwork is different and we're proud of that.
But I'll stop boring you with history here, as this is the Formwork Manual.
Your goal is to get your medical device compliance done, and we're here to support you. Have fun browsing through the Formwork manual and definitely reach out if you have any further questions in our customer support chat in the bottom right corner!
Oliver
Formwork is an eQMS software which startups love to get their medical device compliance done. I started building Formwork back in 2020 after my first job at a medical device software startup, after which I noticed that medical device compliance and especially eQMS software to achieve medical device compliance was entirely broken. You had consultants selling crappy word templates for thousands of euros, and you had eQMS software companies charging five-figure sums for software which looked like it had been written 20 years ago.
OpenRegulatory was and is my attempt to change that. We started out by offering free EU MDR medical device compliance templates, and later started offering a lean, affordable eQMS software, which was targeted towards startups and other founder-led fast-paced companies.
That software became Formwork.
And now in the meantime, a few years later, Formwork has enabled thousands of companies to get their medical device documentation done - with great success, too, as it has passed multiple EU MDR, FDA and Health Canada audits.
While we are OpenRegulatory could have done what most successful startups do - selling the company, or raising prices, or both - we decided to "screw that" and stay true to our mission of supporting startups and enabling small companies to enter the very broken medical device market.
That's why Formwork is still priced extremely affordably. Our pricing is transparent, it's on our website and there are no custom deals and no negotiated discounts. You see what you get. And countless startups have voted with their wallets and decided to trust Formwork with their medical device documentation.
Talking about trust - OpenRegulatory is profitable, 100% founder-owned (by me!) and therefore, arguably, a safer and more sustainable choice than many of our competitors who are funded by venture capital investors which means they are usually not profitable and at risk of getting sold to other companies in the future with very uncertain outcomes, e.g. raising prices or locking in customers by not allowing easy data exports.
Formwork is different and we're proud of that.
But I'll stop boring you with history here, as this is the Formwork Manual.
Your goal is to get your medical device compliance done, and we're here to support you. Have fun browsing through the Formwork manual and definitely reach out if you have any further questions in our customer support chat in the bottom right corner!
Oliver