iso 13485

IVDR Classification Chart

Clinical Research Solutions

Roadmap for Successful IVDR Transition

Roadmap for Successful IVDR Transition: The compliance dates for the In Vitro Diagnostics Regulation (IVDR) will become effective on May 26, 2022. To help you with the IVDD to IVDR transition, we've...

Clinical Research Solutions

ISO13485: The Importance of Management Review

ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS). Section 5...