Quality Systems 

All three of the Medical Device Directives refer 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 standard for quality systems covering most devices. Additionally, all but the highest risk devices can use EN29003. 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.  See also ‘In the USA'.

In line with its Business Solutions approach to Regulatory Affairs, Priory Analysts prides itself on creating quality systems designed for the business, not for the regulatory auditor. Contact us.