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:
- Assistance with building Technical Construction Files
- Risk classification
- Essential requirements and harmonized standards
- Conformity assessment routes
- Labeling and instructions for use
- ISO 13485 implementation using ISOXPRESS (R) 13485 Quality Management System software
- Selection of 13485 registrar
- Selection of Notified Body for product certification and quality systems registration
- Risk management (ISO 14971) using ISOXPRESS (R) 14971 risk management software
IQA provides Authorized Representative Services through our affiliation with CEPARTNER4U: www.cepartner4u.eu
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