ISO 13485 - Medical devices quality management systems

An audited and certified medical device quality management system issued by a third-party is often required, or strongly preferred, by regulatory authorities in most major markets for manufacturers that want to sell medical devices in these markets. This International Standard is suitable for all sizes and types of organizations that are involved in the lifecycle of a medical device and are seeking for improvements on how they are operated and managed. It can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. In this White paper, Besnik Hundozi and Eric Lachapelle from PECB will discuss the key clauses of ISO 13485, the link between ISO 13485 and other standards, the difference between ISO 13485 and ISO 9001 as well as the business benefits of quality management in the medical devices industry.