3 Things You Need to Know About the FDA’s QMSR Alignment With ISO 13485

For years, the medical device industry has been expecting the alignment of the FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. The FDA issued a proposed rule on harmonization with ISO 13485 last year, and now the reality is settling in that a fully aligned Quality Management System Regulation (QMSR) will soon go into effect. Is your medical device company prepared to meet the FDA’s broadened expectations?

In this webinar, medical device industry expert Matt Lowe, chief strategy officer of MasterControl, will help you prepare for the expected changes by examining the differences and similarities between the requirements of Part 820 and ISO 13485, particularly as they apply to managing critical quality processes like corrective action/preventive action (CAPA), customer complaints, and risk. Matt will examine the steps medical device companies should take to prepare for the new QMSR.