Certified with EN ISO 13485 for contract design and development of medical devices for inhalation treatment and implants, the experts of our Department of Regulatory Processes and Documentation are able to provide our customers with ideal support in tapping market opportunities.
The quality of medical devices has a direct impact on product effectiveness and the safety of patients and users. This is why medical device manufacturers and suppliers have to ensure that their products comply with the quality standard EN ISO 13485:2016.
ISO 13485 is a separate standard for a quality management system (QMS), derived from the internationally recognized and accepted ISO 9001 standard. With a focus on medical devices, ISO 13485 defines the requirements for a comprehensively documented QMS. For manufacturers of medical devices, this standard ensures consistency in the design, development, production, installation and distribution of medical devices, thereby ensuring the necessary safety for the intended use.
By having certified the Department of Regulatory Processes and Documentation within our Division of Translational Biomedical Engineering, we are able to provide ideal support in tapping market opportunities for our customers. Companies operating in the market with documentation complying with ISO 13485 demonstrate a commitment to quality to both their clients and the regulatory authorities.
Fraunhofer Institute for Toxicology and Experimental Medicine