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 quality, safety, and regulatory compliance while accelerating the global expansion of alpha-radiation cancer therapy through the manufacturing of the Alpha DaRT. MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently.