The medical 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 putting devices regulated by the relevant EU Directives (medical devices, in-vitro diagnostics, medical devices that can be implanted actively) into circulation. This Standard, which is called EN ISO13485:2012 on a European scale, is harmonized with the applicable Directives in Europe. Therefore, certifi cation acc. to this Standard is obligatory to manufacturers of medical devices in Europe and is also increasingly being required from their suppliers. The Standard establishes requirements for all types of medical devices, which also include services and, acc. to the amending statutes on a European scale (Directive 2007/47/EC), 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