Iso 13485

IVDR Classification Chart

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...

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...