Every medical device Directive refers to the need for a quality system. The extent of the system depends on the risk rating of the device. Low risk devices need a very basic system; high risk devices require a system which covers design, manufacture and final inspection. EN ISO 13485:2003 (usually called ‘13485') is the harmonized (or harmonised) standard for device manufacturing quality systems. ISO 13485 is in effect a version of ISO 9001 which has been extended to cover the additional requirements of medical devices. Typically these are specific cleanliness requirements, regulatory reporting, record retention times and the need for greater confirmatory documentary evidence.

In keeping with a Business Solutions approach to Regulatory Affairs, Priory Analysts works with you to create quality systems that reflect how your business operates, rather than the structure of the regulations. This means that the quality system reflects the language and culture of the manufacturer rather than the terminology of the regulations. In this way, meeting regulatory and quality objectives is a natural business process.