The medical device technology as well as the medical device sector show a high level of innovation. Hundreds of new products are approved weekly, so that existing laws and regulations appear in a new image and creative implementation strategies are required.
ISO 13485 provides an international Standard for enabling manufacturers of medical devices to evidence an effective quality management system. This Standard refers to all the organizations that are operating within the supply chain or are involved in placing devices on the market regulated by the relevant EU regulations (medical devices, in-vitro diagnostics). This standard represents the state of the art. Therefore, certification acc. to this Standard is substantial to manufacturers of medical devices in Europe and is also increasingly being required from their suppliers. The standard specifies requirements for all types of medical devices, which includes services and, according to MDR and IVDR, software. The devices range from sterile to non-sterile medical devices, invasive to non-invasive medical devices as well as non-active medical devices to active implants. >> Read on