Quality Management Systems for Medical Device Manufacturers
ISO 13485:2003 / EN ISO 13485:2012 - two-day course
Dates and Locations:
Price: £750 + VAT
Time: 9am - 4pm
ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
EN ISO 13485:2012 has been harmonised against the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as TÜV SÜD Product Service automatically presumes compliance with specific clauses in these Directives.
The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market. In the European Union, the fulfilment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU Directive requirements is the establishment and independent assessment of the quality system.