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Medical Devices Regulation Booklet


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An increasing number of RQA members have in recent years worked with, or been asked to assist in medical device related projects. The medical device arena is complex; medical devices range from basic tongue depressors to brain stents and pacemakers, with drug/device combination products also included in the family. Information relating to the quality and regulatory aspects of medical devices is not easily accessible, especially if you don't know where to look. RQA identified a need to provide members with a consolidated summary of information on medical devices in one easy booklet.


  1. The Directives
  2. Classification
  3. Pathways To The CE Marking Conformity Assessment Routes
  4. The Role of the Notified Body
  5. Essential Requirements
  6. Quality Risk Management
  7. Clinical Evaluation
  8. Technical Documentation
  9. Quality Management Systems
  10. Post-market surveillance
  11. Combination Products
  12. Other Regulatory Requirements



Zelda Carr, Neil Buckley, David Franks, Louise Olliver, Carolyn Mann, Belinda Pierce, Andrew Tipping, Fraser Smith, Merel de Jonge, Alan Dench, Yvanne Enever, Henny Koch, Kevin Butcher, Hannah Jenkins & Julian Reeves.


Normal Price £20.00 

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First published October 2009, republished July 2013

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