Experts discuss how to prioritize medical and IVD devices under the new MDR/IVDR in Europe.
Regulatory and Compliance
MD+DI asked for reader feedback on the recently-released Netflix documentary, The Bleeding Edge, and our community did not disappoint.
FDA's five-pronged Medical Devices Safety Action Plan, revealed in April, has triggered concern by AdvaMed, Johnson & Johnson, and physician specialty groups.
An MD+DI interview with The Bleeding Edge filmmakers Kirby Dick and Amy Ziering reveals the backstory of how this film came to fruition.
FDA has raised concerns about laser and energy-based devices being marketed for vaginal rejuvenation without adequate evidence to support the use of these devices for that purpose.
Medtech companies could see continued scrutiny of customer relationships as well as of their dealings with FDA, an expert tells MD+DI.
Zimmer Biomet CEO reiterates that patient safety is the company's first priority, and that remediation efforts are progressing "with the sense of urgency."
Be sure to understand Japan’s latest revision to its reimbursement policies, as it could influence your next filing.
Bob Bekian and his company Spotburner are partnering with healthcare firms to produce high quality demonstration videos of medical devices.
Baxter said it is evaluating other potential locations, including contract manufacturers, to support its supply needs if necessary.
Zimmer Biomet said some of FDA's observations during an April inspection may be the byproduct of misunderstandings or disagreements between company personnel and FDA investigators.