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Diving into FDA’s QMSR Alignment with ISO 13485
For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. 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. Now companies are asking if they are prepared to meet FDA’s broadened expectations. The ISO 13485 standard outlines the requirements for a comprehensive quality management system that helps ensure the safety and effectiveness of medical devices throughout their lifecycle.
