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MEDICAL DEVICES
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MEDICAL DEVICE
CLINICAL
INVESTIGATIONS

Understand How to Conduct Clinical Investigations
and Post Market Clinical Follow-up for Medical
Devices

Conference Date: 14-15 Sep 2010
Conference Ref: N9-8310
Fee: £1220 + VAT
Venue: The Rembrandt Hotel, London

Benefits in attending:

  • Understand the affect of regulatory requirements on medical device clinical studies
  • Clarify what is involved in a Clinical Evaluation (Literature Review)
  • Discover how to design pre market and post market studies
  • Know what documentation is needed and what should go in a study master file
  • Discover how to obtain Research Ethics approval in each European Country
  • Plan how to prepare regulatory notifications to the Competent Authorities
  • Understand the key aspects of pre and post market study setup, management, monitoring and close down
  • Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study
  • Discuss how to prepare a paper or presentation for publication and marketing

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