21 CFR 820 to ISO 13485:2016

Per the RAPS Regulatory Focus newsletter, the FDA is considering mapping the applicable FDA device Quality System Regulations (QSR) in 21 CFR 820 to the appropriate ISO 13485:2016 clauses. Reportedly, this change is due to the current global harmonization initiatives regarding quality management systems.

The FDA CDRH proposed rule is expected in early 2019 with final rule adoption sometime in 2020.

The full article can be found here.

Contact a Realtime expert to discuss your design or for help in establishing or updating your Quality Management System, or navigating the compliance pathway, including 21 CFR 820.30 and numerous others.

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Garyld Miles, VP Operations and Engineering