News

Another Notified Body has been approved under the European Medical Device Regulation (EU-MDR): Neoemki LLC from Hungary. This brings the total number…

FDA has published draft guidance to assist the medical device industry in reviewing analytical chemistry studies on biocompatibility of medical…

The FDA has issued its final guidance on the "Electronic Submission Template for Medical Device De Novo Requests." This guidance builds upon the…

This regulation entered into force on 17 August 2023 as the EU Battery Regulation 2023/1542. 

From August 18, 2024, minimum durability and…

RDC 830/2023 came into effect on June 1, 2024, replacing RDC 36/2015. This update aligns Brazil's IVD regulations more closely with Europe's IVDR.

Th…

The EU Commission has updated the timelines for the EUDAMED modules. A significant milestone is the announcement of the finalization in the EU…

AI systems in medical devices introduce a new set of risks and  performance parameters. Without a lifecycle for each model, manufacturers cannot…

Mark your calendars! Next year, we are excited to offer the NSF Summer Camp - Intensive Course for Regulatory Affairs Managers once again. The…

On July 8, 2024, the WHO launched the online platform MeDevIS (Medical Devices Information System). This platform lists 2,301 medical devices used for…