Alpha Tau Medical Ltd., the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, announced the achievement of Medical Device Single Audit Program (MDSAP) 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.
HR Technology Insights: Homecare Homebase Highlights Pennant Services’ Success in Care Integration
“This milestone underscores our ability to expand our manufacturing capabilities expediently and efficiently as we continue to pursue marketing approvals across multiple geographies,” said Uzi Sofer, CEO of Alpha Tau. “We are hopeful that this will also expedite our progress in bringing to market a game-changing product for the treatment of solid tumors.”
“This huge achievement was made possible by the diligent work of our teams across regulatory, QA, R&D, production and engineering, who remain ever committed to delivering high-end innovative quality products while continually increasing production capacity to meet the growing demand for our products in clinical trials,” said Yaniv Sagie, VP of Quality & Regulatory Affairs at Alpha Tau.
HR Technology Insights: St. Croix Hospice Recognized for Gold Standard Care
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
About Alpha DaRT
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
HR Technology Insights: Vit-Best Nutrition Appoints New President
Source – GlobeNewswire
To share your insights, please write to us at news@intentamplify.com
