CE Marking Products

Portland Oregon, CE Marking Company & Consultant – MDD, AIMD, IVDD & PPE Directives

The EU revises its directives as needed and publishes the changes in its Official Journal (OJ). Rather than piecing the information together from the OJ, IQA recommends use of the published consolidated versions of these directives.

IQA provides clients with (CE Mark) consulting services for the following Directives

  • MDD – 93/42/EEC concerning medical devices
  • AIMD – 90/385/EEC relating to active implantable medical devices
  • IVDD – 98/79/EC on in vitro diagnostic medical devices
  • PPE – 89/686/EEC relating to personal protective equipment
  • WEEE – 2002/96/EC on waste electrical and electronic equipment
  • ROHS – 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment

CE marking of medical devices includes product certification and/or quality system certification (ISO 13485) as defined by the conformity assessment routes of the MDD, AIMD, IVDD, and PPE directives.

IQA provides the following consulting services:

IQA provides Authorized Representative Services through our affiliation with CEPARTNER4U: www.cepartner4u.eu

For more information email or call us today at (503) 522-9456.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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