ISO 13485:2003 The certification of a quality management system, specifically for
medical devices, to ISO 9001/ISO 13485(EN 46001)proves advantageous,
and in many cases essential, for medical companies which export their
products to the global market.
CE CE Marking is legally required (mandatory) for products intended for
sale or placed into service in Europe. CE Marking covers an estimated
75% of all products sold today in the EU. The requirements for CE
Marking apply to all manufacturers, whether located within or outside
of the EU.