Alpha Tau Medical Achieves MDSAP Certification: A Major Milestone in Global Expansion of Alpha-Radiation Cancer Therapy
Jerusalem, February 24, 2025 – Alpha Tau Medical Ltd. (Alpha Tau), a pioneering biotech company specializing in the development of innovative alpha-radiation cancer therapy, Alpha DaRT®, is thrilled to announce that it has successfully achieved Medical Device Single Audit Program (MDSAP) certification for its manufacturing facility in Jerusalem. This achievement represents a significant milestone for Alpha Tau as it continues its commitment to maintaining the highest standards of quality, safety, and regulatory compliance.
What is MDSAP Certification?
MDSAP is a program that provides a single audit, based on a risk-based approach, to meet the requirements of multiple regulatory authorities. The certification process is managed by the International Accreditation Forum (IAF) and involves an assessment of a company’s quality management system against the requirements of multiple regulatory authorities, including the US Food and Drug Administration (FDA), European Commission, and Canadian Medical Devices Conformity Assessment System, among others.
Impact on Alpha Tau and Its Customers
The MDSAP certification is a testament to Alpha Tau’s dedication to delivering high-quality, safe, and effective alpha-radiation cancer therapy to its customers. By meeting the rigorous requirements of this certification, the company is able to streamline the regulatory approval process, reducing the time and resources required to bring Alpha DaRT to patients in need. This, in turn, will enable Alpha Tau to expand its global reach and positively impact more lives.
Global Impact of Alpha-Radiation Cancer Therapy
Alpha DaRT is a minimally invasive, non-thermal, alpha-radiation therapy that harnesses the power of short-range alpha-particles to target and destroy cancer cells while minimizing damage to healthy cells. The therapy holds significant promise for treating various types of cancer, including brain, liver, and pancreatic cancer. With the MDSAP certification now in place, Alpha Tau is poised to bring this groundbreaking therapy to more patients around the world.
Looking Ahead
The achievement of MDSAP certification is an important step forward in Alpha Tau’s mission to revolutionize cancer therapy and improve patient outcomes. By continuing to invest in research and development, and collaborating with leading institutions and organizations, Alpha Tau is confident that it will make a significant impact on the global fight against cancer.
- Alpha Tau Medical achieves MDSAP certification for its Jerusalem manufacturing facility.
- MDSAP certification streamlines regulatory approval process and reduces time to market.
- Alpha DaRT, a minimally invasive alpha-radiation therapy, holds promise for treating various types of cancer.
- Alpha Tau’s commitment to quality, safety, and regulatory compliance positions it for global expansion.
As Alpha Tau continues to innovate and grow, the potential impact on individual lives and global health care is immense. The future of cancer therapy is bright, and Alpha Tau is at the forefront of this exciting and transformative field.
Conclusion
Alpha Tau Medical’s achievement of MDSAP certification for its Jerusalem manufacturing facility is a significant milestone in the company’s mission to bring innovative alpha-radiation cancer therapy to patients around the world. This certification will enable Alpha Tau to expand its global reach, streamline regulatory approval processes, and ultimately, positively impact the lives of countless individuals battling various types of cancer. With a commitment to quality, safety, and regulatory compliance, Alpha Tau is poised to revolutionize cancer therapy and make a meaningful difference in the global fight against this disease.
As this technology continues to evolve and progress, it is an exciting time for both Alpha Tau and the cancer research community. The future of cancer therapy is bright, and with companies like Alpha Tau leading the charge, we can look forward to a future where innovative treatments and improved patient outcomes are the norm.
