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 getting the Department of Regulatory Processes and Documentation of our Division of Translational Biomedical Engineering certified, we are able to provide our customers with ideal support in tapping market opportunities – be they seeking to expand at a local level or operating in the international market. Companies operating in the market with documentation complying with ISO 13485 demonstrate a commitment to quality to both their clients and the regulatory authorities.
Our clients benefit from the following advantages:
- Access to European markets due to ISO 13485 compliance
- Comprehensive and reliable support in the development of a safe medical device
- One-stop shop for preparation of the technical documentation