Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...
The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...
Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, ...
The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
Etienne Nichols, a medical device guru and community manager at Greenlight Guru, recently posed an interesting question to his LinkedIn network: If you were in charge, what regulation would you change ...
On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...
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