TEL AVIV, Israel, April 11, 2019 /PRNewswire/ — Alpha Tau Medical, developer of the breakthrough alpha radiation cancer therapy, Alpha DaRT, announced today that it has obtained ISO 13485:2016 certification. The certification was awarded following an audit by the UK’s independent national compliance body, British Standards Institution (BSI).

ISO 13485:2016 is the internationally-recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes.

This certification represents an important milestone for the company. It enables Alpha Tau to continue to develop the Alpha DaRT therapy in compliance with the highest standards for safety, efficacy and product performance, and to make its commercial product available for the first patient treatment, once the Alpha DaRT medical device regulatory file will be approved.

Yaniv Sagie, Quality Assurance and Regulatory Affairs Director of Alpha Tau Medical, said: “This official recognition demonstrates our dedication to ensuring that the infrastructure to develop, manufacture and distribute our therapy is safe, effective and reliable.”

“This is a significant achievement for the company that moves us one step closer to the commercialization of the Alpha DaRT treatment in Europe,” said Uzi Sofer, CEO of Alpha Tau Medical. “In the closely regulated and highly competitive industry of medical device manufacturing, by adhering to the latest ISO certification standard, we are proud to join other leading medical companies, to provide high quality products to our users and patients.”