 Big changes to U.S. medical device quality regulationsOn February 2, 2024, the FDA officially announced its plans to amend 21 CFR Part 820 to align more closely with ISO 13485—the globally recognized standard for medical device quality systems. While many OEMs already follow ISO 13485, those who don’t will now have until February 2, 2026, to make the transition. Here's what you need to know about the shift, what’s changing, and how to prepare.
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About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. |
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