QMSR for MedTech Startups: What Changed for Design Controls in 2026
QMSR took effect February 2, 2026, and FDA now reads design controls through ISO 13485 and a risk-first inspection model. Here is a seven-point checklist MedTech startups can use to get design controls QMSR-ready.
How Design Reviews Prevent Expensive Downstream Problems
Costly medical device problems usually start as small gaps: an unclear requirement, an unrealistic tolerance, a missing test method. Strong cross-functional design reviews catch them early.