by Chad Brueck | Mar 6, 2025 | MDC Blog
by Lezlie Hynes Software continues to play an expanding role in both medical devices (SiMD) and standalone medical devices (SaMD). The latest versions of ISO 14971:2019 Medical devices – Application of risk management to medical devices and ISO/TR 24971:2020 Medical...
by Chad Brueck | Mar 3, 2025 | MDC Blog
by Sruthi Sundaram, PhD The Breakthrough Devices Program by the FDA is designed to expedite the review and development of medical devices and in vitro diagnostics (IVD) that may provide a more effective treatment or diagnosis for life-threatening or irreversibly...
by Chad Brueck | Feb 9, 2025 | MDC Blog
by Lezlie Hynes Conducting Internal Audits for regulated and ISO certified medical device manufacturers and some medical laboratories is required (e.g., FDA, CLSI, ISO 13485, ISO 9001, ISO 17025, ISO 15189, etc.). However, there is also value in conducting these...
by Chad Brueck | Nov 19, 2024 | MDC Blog
by Sruthi Sundaram, PhD The FDA IVD Roundtable is an essential forum for IVD innovators, offering valuable insights into regulatory updates, industry trends, and best practices. This November, we’re providing quick daily takeaways from the roundtable to keep you...
by Chad Brueck | Oct 23, 2024 | MDC Blog
by Audrey Skeen Regulation: 21 CFR part 820 Issuing Authority: Food and Drug Administration (FDA) Effective Date: 2 February 2026 (FAQ issued 7 August 2024) FDA Amends 21 CFR Part 820 The FDA has amended 21 CFR part 820 by incorporating ISO 13485:2016, the...
