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Ep 31 of Medtech Snapshot features Krystal Santiago sharing with us strategies for working with regulatory agencies during a submission and how utilizing an intermediary can be beneficial. This impacts decision making with clinical studies, product codes and requirements, pre-submission planning, etc. Did you miss the last 30 episodes of Medtech Snapshot? If so, check out our archives at https://www.sqr1services.com/white-papers/category/snapshot #medtechsnapshot #snapshot #medtech #medicaldevice #FDA #regulatory #productsubmission #compliance #510k #PMA 
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Medtech Snapshot Part 2:2 continues the discussion as Trisha Aure covers considerations when transitioning from 21 CFR 820 to ISO 13485.
Hear how due diligence and training play a crucial role in the transition process and the impact it has on our employees. #iso13485 #regulation #compliance #fda #21CFR #riskmanagement #medicaldevice #medtech #news #podcast #snapshot #regulatoryaffairs  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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