JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
Seeking Alpha

Kane Biotech Receives ISO 13485:2016 MDSAP Quality Certification

WINNIPEG, Manitoba, July 17, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (KNE:CA) (TSX-V:KNE; OTCQB:KNBIF) (“Kane Biotech” or “Kane”) announces that it has received ISO 13485:2016 Medical Device Single ...
Seeking Alpha

Validated for Global Scale: DIAGNOS Passes Annual MDSAP Audit, Solidifying the Pathway to Approvals with Health Canada & FDA

BROSSARD, Quebec, Oct. 08, 2025 (GLOBE NEWSWIRE) -- DIAGNOS Inc. (ADK:CA) (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health ...
Business Wire

Tasso Recommended for Certification from Medical Device Single Audit Program (MDSAP)

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that it has been recommended for certification from the ...
BioWorld

MDSAP remote audit program extended one last time

As was the case for all medical device inspections, the Medical Device Single Audit Program (MDSAP) was hampered by the COVID-19 pandemic, but the participant regulators agreed to allow the use of ...
Nasdaq

Alpha Tau Medical Achieves MDSAP Certification for Jerusalem Manufacturing Facility

Alpha Tau Medical Ltd. announced that it has achieved Medical Device Single Audit Program (MDSAP) certification for its manufacturing facility in Jerusalem, which is a key step in ensuring quality, ...
Nasdaq

Alpha Tau Receives Medical Device Single Audit Program (MDSAP) Certification

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®, ...
abc27

Femasys Inc. MDSAP Surveillance Audit Successfully Completed

ATLANTA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, ...
Business Wire

Receipt of MDSAP Certification for Sensus Healthcare’s Full SRT Product Portfolio to Streamline and Accelerate International Sales Efforts

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 ...
Business Insider

Alpha Tau receives MDSAP certification

Alpha Tau (DRTS) Medical announced the achievement of Medical Device Single Audit Program certification for the company’s manufacturing facility in Jerusalem, as part of the Company’s commitment to ...
Medicine Buffalo

3 Day MDSAP Training (MDSAP24)

Medical device companies are acutely familiar with FDA regulations and likely certified to, or working toward, a quality management standard like ISO 13485. Those that seek to expand business need to ...