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Medical Device Studies: Clinical Evidence (London, United Kingdom - May 13-14, 2019)

/EIN News/ -- Dublin, May 02, 2019 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Clinical Evidence" conference has been added to ResearchAndMarkets.com's offering.

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Clinical evidence is key to bringing a device to market and is a very important aspect of post-market evidence gathering to meet the legislation. The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market.

This course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices. It will cover the full range of activities that should be applied during the collection of clinical evidence for both pre- and post- market studies and will also provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies and help them to run studies in Europe and other countries. Delegates will benefit from the advice and tips on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant with the new MDR.

Benefits of attending

  • Understand the regulatory requirements and guidance applicable to clinical evidence
  • Clarification on Clinical Evaluations (Literature Reviews)
  • Understand what is required in terms of clinical data prior to CE marking and post CE mark
  • Know what documentation is needed for the pre-and post-market phases of clinical data collection
  • Discover how to conduct a clinical investigation and post market clinical follow-up study
  • Plan how to prepare regulatory notifications to the Competent Authorities and obtain other necessary approvals
  • Understand the key aspects of pre and post market study setup, management, monitoring and close down
  • Discuss how to prepare a paper or presentation for publication and marketing
  • Understand the differences between drugs and devices

Agenda:

Programme day one

  • The regulatory aspects of gathering clinical evidence for devices
  • Conducting a pre-market clinical evaluation and the literature review
  • Conducting a pre-market (regulatory) clinical investigation
  • Documentation for pre-market (regulatory) clinical investigation. What documentation is needed?
  • How to obtain the necessary approvals for pre-market studies
  • The differences between drugs and devices

Programme day two

  • Study management and monitoring of regulatory clinical investigation
  • How to write a final study report for a regulatory clinical investigation pre-market study
  • Post-market clinical follow-up studies
  • Current key issues affecting clinical evidence for medical devices

For more information about this conference visit https://www.researchandmarkets.com/r/i4dah


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Related Topics: Medical Devices

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