Medical devices

Medical device technology, and the medical device industry, is experiencing a high level of innovation. Hundreds of new products are approved every week, challenging existing laws and regulations and requiring creative implementation strategies.

ISO 13485 is an international standard enabling medical device manufacturers to demonstrate an effective quality management system. This standard applies to all organizations operating in the supply chain or involved in the marketing of products regulated by relevant EU regulations (medical devices, in vitro diagnostics). This standard represents the state of the art. Therefore, certification to this standard is essential for medical device manufacturers in Europe and is increasingly required of their suppliers. The standard specifies requirements for all types of medical devices, including services and, in accordance with the MDR and IVDR, software. These devices include both sterile and non-sterile medical devices, invasive and non-invasive medical devices, as well as non-active medical devices and active implants. >> Read more