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Written by Daniel Saffer
EMC testing of medical devices traditionally focuses on basic safety and essential performance. But what happens to functions that, while not directly safety-critical, nevertheless have a ...
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. ...