Striving to provide uncompromised products quality, safety and efficiency to all its customers, users and their patients, Pristem SA has implemented a quality management system that meets the requirements of ISO 13485:2016 standard.
ISO 13485 is the most widely accepted model for regulating quality management systems of medical device manufacturers worldwide. It enables the company to place emphasis on the risks linked to the safety and performance of medical devices and their compliance with the highest medical standards and regulatory requirements as well as the demands of customers.
ISO 13485 Certification resulted from the successful completion of the evaluation and audit of Pristem Quality Management System by TÜV SÜD, one of the leading global certification organizations.
Nicolas Le Paven, Pristem Quality Manager, said: “Achieving ISO 13485 certification was an important milestone for Pristem and establishes us as a credible player in the Medtech industry. This certification is a key step to obtain the CE mark for Pristem innovative products. Our products and solutions, designed, developed and manufactured in compliance with the most stringent regulations and quality standards, will allow healthcare providers, anywhere in the world, to provide uninterrupted services and improved outcomes for patients.”