2026-10-12
$54M of new funding is targeting medical device and regulatory affairs
2 funded companies building into medical device and regulatory affairs. The work in scope is what the Head of Regulatory Affairs owns today.
The funding
The only Notified Body specialised in software and AI - a medical device certification process built for SaMD and AIaMD manufacturers.
Scarlet raises $50M Series B to accelerate AI medical device certification →Rizhao Bigway Medical Device Co., Ltd. is a growing enterprise dedicated to the health of medical consumables. With a customer-centric approach, we offer customized solutions.
Eye-care AI firm Bigway Medical raises $4.48M Series B extension →What it means
Capital arriving in a function is a reliable leading indicator. It does not mean the incumbents are wrong, and it does not mean these companies will succeed. It means that within the next few quarters the people who run this work will be asked what their function is doing about it, and the honest answer has to start with where that function actually stands.
So we built the assessment for it. Not a purchase decision, a structured set of questions to take to your own team.