Terapet Achieved ISO 13485:2016 certification for its Quality Management System
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Terapet’s is a Geneva-based, CERN spinoff, whose proprietary technology is designed to enhance precision in nuclear medicine and radiation therapy by providing advanced imaging and radiation verification solutions. The company is currently developing systems intended to support improved diagnostic accuracy and treatment outcomes in oncology and beyond.
“This certification provides a solid foundation as we move forward in clinical development and commercialization” concluded the CEO. “It demonstrates our commitment not only to innovation but also to quality, compliance, and ultimately, to improving patient care. Our team remains dedicated to setting new standards in the industry. Quality, safety, and innovation are at the heart of everything we do and ISO 13485:2016 is one more step toward delivering on that vision”.
The ISO 13485:2016 standard is the internationally recognized benchmark for quality management systems in the medical device industry. It sets out the requirements that organizations must meet to consistently deliver safe and effective medical devices. This certification applies across all stages of a product’s life cycle, including design and development, production, storage, and servicing and it comes at a pivotal time for Terapet, as the company advances the development of our flagship devices, Qualγscan and Nuclγscan, two solutions poised to transform precision in particle therapy and nuclear medicine, respectively.
“Achieving ISO 13485:2016 is not just a checkbox, it’s a reflection of the rigorous processes we’ve put in place to ensure quality at every step, from design to deployment”, said Christina Vallgren CEO and Co-founder at Terapet. “It demonstrates that we’re not only building innovative products, but doing so with a deep responsibility toward the patients and professionals who will ultimately rely on our technology. This achievement reflects the culture of quality and risk-based thinking embedded across our organization. It ensures that we are well-positioned to bring our novel imaging solutions to clinical markets with the highest standards of safety and performance”.
Source: Terapet