Trade Articles

Requests for Additional Information During EU Audits

Managing Testing Strategies Under the EU MDR

Exceeding Regulatory Requirements: Beyond the Checklist 

The OEM’s Roadmap to Navigating MDR

Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

Preparing For MDR? Start With A Gap Analysis

Preparing for MDR: Don’t Forget about Class I Reusable Devices

Pre-Clinical Medical Device Testing Under ISO 10993-1 and the MDR