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Medical
Where a directive requires products to be independently tested, inspected or certified, this must be undertaken by a body approved for the purpose of the directive by a government of the community and notified to the European Commission. Notified bodies can be laboratories, certification bodies or inspection bodies.
Bodies can be notified for all conformity assessment routes in the directive or for individual ones. The requirement of the routes will determine the type of organisation which is notified. For example, for a route which stipulates type-examination the notified body would normally be a test house or product certification body. For modules stipulating ISO 9001 approval the notified body would be a quality management system certification body.
If you require more information regarding one of the services, please download the detailed enquiry form relevant to your enquiry in word format and email it back to us at enquiries@lrqa.co.uk
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LRQA provides services to:
LRQA provides services to:
- In-vitro Diagnostics Medical Devices Directive
- ISO 13485
- Medical Devices Directive
- Purchase Standards (external link - clickhere for terms and conditions)
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Medical Devices
17 May 2012
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