Emanuel Wasson

Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing. FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance. While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies.

Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | January 7, 2025 FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance. Resonant Wireless Power Transfer In Implantable Medical Devices Battery life and replacements can be problematic for implantable medical devices.

By Mayur Patel, Hilde Viroux, and Emanuel Wasson FDA’s harmonization of the Quality System (QS) Regulation with ISO 13485 was long expected. It is welcomed by the global medtech companies, as other jurisdictions like the EU already use ISO 13485 as the basis for the quality management system (QMS). Aligning 21 CFR 820 with ISO 13485 gives those companies one global standard for QMS compliance.