Webinar on Device Registries as PMCF tools

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(No Transcript)
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Device Registries as PMCF tools

• The new 2017/745/EU Medical Device Regulations
  (MDR) require increased emphasis on Post Market
  Clinical Follow-Up (PMCF). Device manufacturers
  tend to equate this with post-market clinical
  investigations which are considered to be costly
  and time intensive. A potential method for
  acquiring cost and time effective data is the use
  of a device specific registry or registries
  developed by consortiums.
• This webinar will provide an overview of PMCF
  requirements, outline elements of a well-designed
  registry and offer advice about known, potential
  pitfalls.
• Examples of existing collaborative registries
  will be reviewed as a potential data source for
  device manufacturers.
• Additionally, the presenters will discuss how
  registry data can be utilized in required
  Clinical Evaluation Reports (CER) to meet PMCF
  needs as required under MedDev 2.7/1, rev 4 and
  the new MDR.

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About Our Speaker

• Pamela Wolfe, MBA, MS, CCRP
• Regulatory Clinical Expert (Medical Device)
• Register here https//www.makrocare.com/webinar-r
  egistration-for-device-registries-as-pmcf-tools