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Regulatory & Quality

Highlights
Image of a woman using a sleep apnea machine (CPAP) with overlaid text reading "It was a catastrophic series of errors" referring to a massive recall by Philips
Philips Accused of a Dangerous Secret
Sep 28, 2023
An investigative report takes Philips to task for keeping complaints about its dangerous breathing machines secret for more than a decade.
Medical Device Regulation
EU MDR Challenges Spark Questions
Sep 26, 2023
HungeroTrial’s Antal Solyom highlights the overwhelming amount of re-certification applications, noting that some notified bodies aren’t even accepting new device applications.
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