A number of different European Directives require manufacturers of medical devices to implement and maintain a quality management system as part of their compliance program. Different routes and standards can be used to comply with the Directives:
mdi Europa will help you to identify the applicable legislation you have to follow and will lead you through the entire process. We offer draft documents, templates and assistance in developing your own, customized quality management system. If requested, we will assist in compiling your own quality manual and procedures.
Specifically for medical device manufacturers, ISO 13485 was adopted.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.