Manufacturers and distributors of Medical Devices are subject to a range of regulations and requirements that can be complex and confusing.

ISO 13485:2003 was devised with the aim (hope?) of harmonizing the requirements across the various markets around the world. It is harmonized with the various EU Medical Devices directives and is cited as one of the route to ensure compliance.

It is a stand-alone standard but is based on the previous version of the ISO 9001 standard (ISO 9001:2000) and is written in such a way that it is easy to see what additional requirements are imposed (as in some cases what requirements are excluded). Although it is based on the process approach, to satisfy the additional requirements for traceability etc., ISO 13485 is more prescriptive that 9001 and requires a number of additional documented procedures and understandably, the management of risk is a key element.

ISO 13485 is rapidly becoming the expected route to demonstrate compliance with the various Medical device directive (Medical Device CE mark) for the higher risk devices (class IIa and above). In most cases certification against the standard is not mandatory but Notified bodies involved in assessment will carry out there review based on the points in the standard.

The relationship to the previous Medical Device quality system standards and ISO9001 is given in the diagram below.