What changed when 21 CFR 820 became the QMSR
How 21 CFR part 820 became the Quality Management System Regulation, which sections were removed or reserved, and where each requirement now sits.
Tag: quality
4 posts
EU quality system requirements for medical devices
How Regulation (EU) 2017/745 requires manufacturers to run a quality management system, from design through surveillance, and who must oversee it.
FDA quality system requirements for medical devices
How 21 CFR Part 820 applies the QMSR to device manufacturers, which devices need design and development controls and how combination products are treated.
What CLIA requires of a laboratory before it reports a result
How CLIA certification, performance specification validation and personnel qualifications apply to a laboratory before it reports a patient test result.