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Meet the training leader

  • Richard Tully
  • Director
  • Compliant Medical Devices Ltd
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Course description

The new Medical Devices Regulation has provided a radical shake up of requirements for medical devices. It is arguable that the Post-Market Surveillance elements have not changed much, but the prescriptive nature of those elements in the Regulation leaves the current approach of most manufacturers falling short of the law. The new requirements tie Post-Market Surveillance to Risk analysis, Clinical Evaluation and Vigilance. This means that nothing short of a joined-up approach will be acceptable in the future. This course starts by accepting the above statements and presents some of the solutions which Medical Device Manufacturers could adopt.

Key topics

Complaint handling

Implementation challenges & procedural solutions

Data handling

Post-Market Surveillance reporting

Social media and Post-Market Surveillance reporting

Updating Clinical Evaluation

Dealing with off-label use

Incident reporting examples

Benefits of attending

Understand the current regulatory & compliance framework for medical devices

Gain insights into effective & successful post-market surveillance under the new EU MDR

Practice developing and implementing post-market surveillance plans

Explore best practices for gathering clinical and safetyrelated data

Improve your complaint handling, risk management and CAPA

Get tips for PMSR and PSUR under the EU MDR

Tickets

Online Live Stream

from 1296 € Buy

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