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.
Medical Device Commercialization Readiness: What Investors Expect in 2026
Medtech venture capital in 2026 is flowing to de-risked programs. Here are seven commercialization readiness questions medical device founders should answer before the next raise, from design inputs and FDA pathway to manufacturability.