LinkedIn·Thursday, 13 August 2026·13d ago

If I had to bring an EU MDR-compliant medical device to market in 3 months, here's what I'd actually do. 🇪🇺 Most teams treat this as a…

Hermanni Aho

CEO & Co-Founder of Aident | Dentistry at University of Helsinki

If I had to bring an EU MDR-compliant medical device to market in 3 months, here's what I'd actually do. 🇪🇺 Most teams treat this as a linear process: build → certify → sell. That's how you miss the deadline. It has to run in parallel from day one. 1. Pilot and build with clinicians, not in a vacuum. Get the product in front of real clinical users immediately, even a rough version. Every week you build without clinician feedback is a week you'll spend re-building later. The fastest path to a device people actually adopt is co-developing it with the people who'll use it daily. 2. Own the regulatory documentation; don't outsource your understanding of it. Bring in consultants for the narrow, specialist gaps. But keep the core documentation and the underlying logic in-house. If you don't understand your own technical file, you can't move fast when a reviewer asks a question, and you'll pay consultants to re-explain your own product back to you. In-house ownership + targeted consultant support is both faster and cheaper than handing the whole thing off. 3. Design onboarding in from the start, not after launch. A certified device sitting unused isn't a launch. Build the onboarding flow; training, support, feedback loop alongside the product itself, so the day you're compliant is the day clinics can actually start using it. ⌛ 3 months is realistic for a Class I self-declaration path with focused execution. Higher-risk classes requiring Notified Body review run on a very different timeline.

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