2019 US Regulatory Review: Risk Management, EtO, Quality, Medicare, QSR/ISO 13485 Harmonization Hot-Button Topics For Industry
• By Shawn M. Schmitt
The US medtech regulatory landscape in 2019 was capped at both ends by news of an ambitious rewrite of risk management standard ISO 14971, which was finalized in December. The international standard – used by most manufacturers that make and distribute medical devices within the United States – instructs device makers on how to best put together a risk management program. Other news of interest to readers last year included a rewrite of the US FDA’s Quality System Regulation (QSR) to harmonize it with ISO 13485, expanded Medicare coverage, troubles with ethylene oxide (EtO) used to sterilize devices – and much more. Here are 2019’s 10 most popular US regulation and policy stories from Medtech Insight.
The US medtech regulatory landscape in 2019 was capped at both ends by news of an ambitious rewrite of a popular international risk management standard that’s used by most manufacturers that make and distribute medical devices within the United States.
Last January, Medtech Insight provided an in-depth look at the revision process for ISO 14971; it was the story...
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