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Officials from some notified bodies say proposals to update the EU Medical Device and IVD Regulations go too far in tying their hands and taking away important authorities that allow them to ensure quality medical devices and diagnostics reach the market.
A Sydney-based start-up makes vascular modeling quick and simple for dialysis patients amid a shortage of qualified specialists.
South Korean regulators have released multiple policies impacting medtech products, including a new fast-track market pathway. Excerpted from Pathways’ Picks January 28: South Korea Fast Track, Minnesota Letter, PPE Supply Ideas, and More.