FormlyAI

Hey it’s Spencer, CEO at FormlyAI We built this tool after hearing over and over how medical device founders struggle with certification. Watching great medical device products fall short during or even before the certification process was started was frustrating for me to watch. Every medical device needs to go through "certification". This process involves standardized processes for designing, developing, and testing your device and usually results in over 100 documents to prove your product meets requirements to be on the market. We talked to a lot of startups and most bootstrapped startups usually buy or try to find free templates for these documents and hack it together themselves. Ones that had at least a little funding would try to pay consultants to do it for them, but that would often put them back $30-$100K. Our team has built and certified medical devices in startups and worked for regulators like the FDA ourselves. We tried to build a new approach to make this process more affordable and faster for startups. Something that non-experts would love to use and would hold up to the highest regulatory standards. We have been building our software for over a year together with our design customers and just certified our first couple devices in the EU. We also just launched a free trial where you can create a bunch of documentation absolutely for free and get to experience the AI in action. We would love your feedback so that we can make the experience as clean as possible for founders and startups. Please let us know what you like or think could be improved. Hope you enjoy it!

@spencertodd, major kudos for tackling regulations. FormlyAI seems like a much-needed breather for medical startups.

Having advised Formly since inception, it's been amazing to see the team disrupt an industry they could have made a ton of money in as consultants with a product that truly democratizes a complicated process, bringing innovative medical devices to market quickly!

Hell yea

go Formly! \o/

This concept not only simplifies a critical process but also has the potential to significantly reduce costs and time to market for medical device companies. Well done!