Preparing for the Upcoming FDA Quality Management System Regulation

Speakers: Ed Bills & Christie Jonhson

About this course

Over the last few months FDA’s CDRH has been indicating in various presentations and articles that the Proposed Quality Management System Regulation is expected to become Final in December of 2023. While most companies are familiar with ISO 13485:2016, which will be the basis for the regulation, and that standard is been assessed to be 95% the same as the current 21 CFR 820 regulation, there may be some other items creeping into the new regulation.

Curriculum0 hr 50 min

Welcome!
Session Recording 0 hr 50 min

About this course

Over the last few months FDA’s CDRH has been indicating in various presentations and articles that the Proposed Quality Management System Regulation is expected to become Final in December of 2023. While most companies are familiar with ISO 13485:2016, which will be the basis for the regulation, and that standard is been assessed to be 95% the same as the current 21 CFR 820 regulation, there may be some other items creeping into the new regulation.

Curriculum0 hr 50 min

Welcome!
Session Recording 0 hr 50 min