With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications ...
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.
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 ...
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. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT ®, ...
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