In IQA's opinion, the European Medical Devices Directive is an intelligent, straightforward directive that has been successfully transposed into the national laws of the 26 member states of the European Union. Entering this market of 400⁺ million consumers plus other markets with similar requirements is an opportunity US manufacturers of medical devices should seriously consider.

IQA can help you find your way in

• General understanding of the MDD (93/42/EEC)

• The definition of "manufacturer"

• Manufacturers responsibility upon placing a product onto the market

• Essential requirements

• Conformity routes (annexes)

• Quality management system requirements (ISO 13485:2003)

• Annex X - Clinical evaluation

• Usability

• Harmonized standards and their role

• Risk management (ISO 14971:2007)

• Role of Notified body, ISO 13485 registrar, and  Authorized Representative

• Technical Construction File

• Other directives (WEEE, ROHS and REACH)

For more information on the medical devices directive (93/42/EEC)

Please contact IQA at 503 522 9456 or email: info@iqa.com