GUIDES
Practical companions to the regulatory reference set — written for the decisions a founder actually has to make, in the order they usually come up.
How SaMD risk classification actually works: the IMDRF framework’s two axes, how they feed EU MDR Rule 11 and FDA classification, and where founders get it wrong.
SaMD Risk Classification Explained (IMDRF Framework) →A practical guide to IEC 62304 for founders: software safety classes A, B and C, what SOUP management actually requires, and how architecture becomes a regulatory lever.
IEC 62304 for Startup Founders: A Practical Guide →How to choose a notified body and plan an EU MDR certification timeline for SaMD: what actually gates the schedule, and how early founders should budget for it.
EU MDR Notified Body Selection & Timeline Planning for Founders →EU MDR Class IIa software explained: how Rule 11 gets you there, what conformity assessment actually requires, and the QMS and evidence obligations that follow.
EU MDR Class IIa Software: What Founders Need to Know →SaMD consultant or an in-house regulatory hire: the real tradeoffs for early founders, what each actually costs, and when the calculus flips.
SaMD Consultant vs. In-House Regulatory Hire: What Early Founders Should Choose →A limited number of advisory conversations are taken on at any time.
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