Holger Wagner, Head of Regulatory Affairs at Drägerwerk AG, has spearheaded transformative advancements in global compliance. With more than 17 years of experience, including a couple of years as a ...

DITTA Offers Tips to Tackle MDSAP Issues In a recent comment to the US Food and Drug Administration (FDA), a global medical technology organization comprised of several industry trade associations ...

A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.

The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA ...

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Medical Device Single Audit Programme (MDSAP) (June 25th - June 26th, 2026)" training has been added to ResearchAndMarkets.com's offering. The Medical ...

SANTA ANA, Calif., June 5, 2025 /PRNewswire/ -- Autonomous Medical Devices Incorporated (AMDI), a developer of ultrafast PCR-based diagnostics, announced today the successful completion of its ...

ATLANTA, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to ...

JERUSALEM, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (DRTS) ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha ...

Medical device manufacturers face a labyrinth of audit and inspection regimes, each with unique demands that can make global compliance feel like a high-stakes balancing act. This article examines the ...

BOCA RATON, Fla.--(BUSINESS WIRE)--Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for ...

PLEASANTON, Calif.--(BUSINESS WIRE)--RadiusXR, a leading innovator in digital health technology, is proud to announce that it has received ISO 13485 certification and the enhanced Medical Device ...

TORONTO, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, ...