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Written by Daniel Saffer
The new EU Battery Regulation was adopted in 2023 and is being phased in. Battery Regulation 2023/1542 can have a very significant impact on medical technology, particularly on medical device manufacturers. ...
Why FPGAs in medical devices are increasingly becoming the focus of software audits and how you can avoid regulatory risks early on. When programmable logic suddenly ends up in a software audit, things can quickly get uncomfortable. ...
Many medical technology companies face the central challenge of transferring a developed medical device from development to series production – while complying with MDR, ISO 13485 and full ...