TAE Life Sciences Achieves ISO 13485 Certification, Marking a Major Milestone in Quality and Regulatory Excellence
Audit Concluded with Zero Findings, Underscoring the Company's Commitment to Patient Safety and Medical Device Quality
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TAE Life Sciences (TLS), a global leader in accelerator-based Boron Neutron Capture Therapy (BNCT), today announced it has received ISO 13485 certification, the internationally recognized standard for quality management systems in the medical device industry. The milestone reflects the company’s commitment to delivering safe, high-quality medical technologies and maintaining the highest standards of regulatory compliance.
A Defining Milestone for TAE Life Sciences
ISO 13485 certification confirms that TAE Life Sciences has implemented and maintains a robust quality management system (QMS) encompassing the design, development, manufacturing, installation, and support of its medical technologies. The standard places an explicit focus on patient safety, product quality, and continuous improvement principles that are foundational to TLS’s mission of bringing BNCT-based cancer treatment to patients worldwide.
“Achieving ISO 13485 certification is a defining milestone for TAE Life Sciences and a testament to the dedication of our entire organization,” said Rob Hill, CEO of TAE Life Sciences. “This certification reflects not only the rigor of our quality management systems but the deep commitment of our teams to ensuring every aspect of our work meets the highest standards of safety and excellence. It positions us well for the next phase of our growth.”
The certification was awarded following a comprehensive audit conducted by BSI (British Standards Institution), a globally recognized leader in medical device certification and regulatory assessment. The audit concluded with zero findings, an exceptional outcome that reflects the depth of preparation and the maturity of the quality systems TAE Life Sciences has established.
A Foundation for Future Growth and Global Expansion
The ISO 13485 certification establishes a critical foundation for TAE Life Sciences’ next phase of development, serving as a key enabler for future product certifications, global market expansion, and alignment with evolving international regulatory requirements while also strengthening the company’s credibility with hospital partners, research institutions, and regulatory bodies worldwide.
About TAE Life Sciences
TAE Life Sciences is pioneering next-generation BNCT with a pipeline of proprietary boron drugs and accelerator-based neutron systems, advancing precision radiation therapy and combination regimens to improve survival for patients with hard-to-treat cancers. TAE Life Sciences is a minority-owned subsidiary of TAE Technologies. TAE Technologies is a leading fusion power company based in Southern California, USA. For more information, visit www.taelifesciences.com.
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