Webinar on Medical Device PMS & PMCF: Challenges & Opportunities

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(No Transcript)
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Medical Device PMS PMCF Challenges
Opportunities

• The new 2017/745/EU Medical Device
  Regulations (MDR-2020) require increased emphasis
  on Post- Market Clinical Follow-Up (PMCF) as a
  part of clinical evaluation to demonstrate
  conformity to safety and performance of devices.
  Many device manufacturers are unaccustomed to
  conducting post- marketing clinical studies and
  tend to regard study activity as both costly and
  time-intensive. Proper design, planning and
  execution of PMCF studies are essential to ensure
  return on investments. This webinar will focus on
  pitfalls and challenges in planning, conducting,
  and managing PMCF studies. It will discuss
  approaches that can be utilized to optimize
  resources and mitigate risk.
• The webinar will cover the following topics
• Protocol development to support business needs
• Study conduct in compliance with ISO14155
• Collecting safety data
• Centralized monitoring
• Tools consideration
• .

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About Our Speaker

• Mary Majer Clinical Subject Matter Expert,
  Medical Devices
• Register here https//www.makrocare.com/webinar-r
  egistration-for-medical-device-pms-pmcf-challenges
  -opportunities