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 13485:2003 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.
In the course of the conformity review procedures stated in the relevant Directives, the safety, security and functionality of medical devices need to be demonstrated so that these products can be registered. As for conformity reviews in Europe acc. to Annex II (complete quality management system) and Annex V (quality assurance in production), demonstration of a quality management system is an important prerequisite for obtaining registration and thus the right to sell medical devices in Europe or to put them into circulation (CE marking).
ISO 13485 has some features that are congruent with those of other management systems, especially ISO 9001. An additional focus having to be placed on complying with laws relevant to quality as well as risk management acc. to ISO 14971. The advantages for organizations do not only consist in the registration aspects but also in transparency of the organizations’ own performance, operations following defi ned processes and the fact that the organization is made aware of legal changes. Furthermore, effective actions for risk management can help to minimize and thus control risks in connection with the devices concerned.