TL;DR A Q-Submission (most often a Pre-Sub) is a free, formal way to get FDA’s written feedback on your device and your submission plan before you file. You send a short package with specific questions, FDA responds in writing within about 75 days, and they usually offer a
A few weeks ago, the FDA sent a warning letter to Purolea Cosmetics Lab. It's been getting a lot of attention, mostly framed as a warning shot at AI in pharmaceutical manufacturing. "FDA says AI is a liability." That kind of thing. I want to offer
Formly's new traceability matrix auto-links every requirement from User Needs through Validation, exposes that traceability graph to AI agents via MCP, and finally looks like something worth using.
Formly now has an MCP server. Connect your Formly workspace directly to Claude or GPT and run regulatory research, standards lookup, and expert review without switching tools.
Compared to other regulatory authorities across the world, the FDA’s approach to regulations and engaging with companies looking to clear their medical devices is unique. The predicate system, enforcement discretion products, and the De Novo pathway, to name a few, are regulatory concepts that are unlike most other countries.
New capital to accelerate US market expansion, scale EU operations, and further develop its AI-powered platform that has already saved clients an average of $70K and reduced time-to-market tenfold. CHARLESTON, September 11, 2025 – FormlyAI, the only AI-native solution for medical device certification, today announced the closure of a $2M seed
TL;DR If you're building a medical device, ISO 14971 is your blueprint for making sure it’s safe, and not just “we hope it doesn’t explode” safe. It's a structured way to think through what could go wrong, how bad that would be, how
TL;DR If you're building a medical device, ISO 14971 is a necessity as it is your blueprint for safety. It’s a formal process for figuring out what could possibly go wrong (hazards and harms), so you can manage those risks before they ever reach a patient.
TL;DR (too lazy, didn’t read) Medical devices need to meet specific performance and safety requirements called GSPRs (General Safety and Performance Requirements) before they can be sold in Europe. Essentially it's like a super-detailed safety checklist that ensures medical devices are safe and work like they
TL;DR (too lazy, didn’t read) IEC 62304 is basically the rulebook for medical device software development. Whether you're creating a standalone medical app or software that's built into medical devices, this standard tells you how to do it safely and properly. The standard has
TL;DR (too lazy, didn’t read) Process validation is basically making sure medical devices are manufactured consistently and safely, every time they're made. It's like having a foolproof recipe that guarantees your dish comes out perfect, except instead of a souffle, we're talking
We are excited to announce a new partnership between FormlyAI and QbD Group, a global leader in life sciences consultancy. This collaboration marks a significant step forward in enhancing efficiency and innovation in the life sciences industry. QbD Group, renowned for their comprehensive solutions across the life sciences sector, supports
