Navigating the complexities of medical device compliance.
How AI-powered SaMD manufacturers navigate dual compliance under EU MDR and the EU AI Act. Covers Articles 9-15, MDR overlap mapping, and the practical 5-step compliance pathway before August 2027.
The 10 most common FDA Form 483 findings hitting medical device manufacturers in 2026. Updated for QMSR with actionable fixes from real inspection data.
FDA has been explicit: ISO 13485 certification does not equal QMSR compliance. The agency does not rely on third-party certificates as evidence of compliance. Here are the seven gaps FDA investigators will target first.
The FDA has retired QSIT and introduced a new risk-based inspection framework under QMSR. Learn what investigators now look for, the thread-pulling approach, and the top 5 deficiencies being cited in 2026.
The FDA QMSR transition deadline is February 2026. Learn what's changing from QSR to QMSR, key differences, and how to prepare your quality system.
Regulatory Excellence for Device Manufacturers. Elite Quality & Regulatory consultancy specializing in ISO 13485, FDA compliance, and medical device manufacturing excellence.
© 2026 VigilaMed Ltd. All rights reserved. Serving Class I, II, and III device manufacturers across UK, EU, and US markets.
