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Home » Store » Medical Devices » Postmarket Surveillance Under EU-MDR: Preparing for New Requirements

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Postmarket Surveillance Under EU-MDR

Postmarket Surveillance Under EU-MDR: Preparing for New Requirements

$397.00
Medical Devices

Product Details

The new EU-MDR is scheduled to take effect in May 2021.

What reports are required for your postmarket surveillance (PMS) system? When do you need to prepare a postmarket clinical follow-up (PMCF) What should you include in your PMCF plan? How do you link PMS data, PMCF data and risk management?

You need to fully understand the EU-MDR’s PMS requirements and how they interconnect.

Postmarket Surveillance Under EU-MDR: Preparing for New Requirements maps out the requirements that are spread out among various articles and annexes of the mammoth regulation. Don’t miss a step in building your PMS plan:

  • Understand the requirements for periodic safety update reports
  • Create a summary of safety and clinical performance
  • Identify and report serious incidents
  • Determine if field safety corrective action is needed
  • Transmit safety reports while the EUDAMED database is being updated (projected to finish in 2022).

The report also includes valuable tools. You’ll receive a template for reporting serious incidents, guidance on preparing summaries of safety and clinical performance and a multi-part Excel spreadsheet to help you apply all the EU-MDR postmarket safety requirements.

Ensure you’ll stay current with the EU’s new PMS requirements. Order your copy today.

Who Will Benefit

  • Quality management staff
  • Regulatory compliance staff

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ISBN-13:
978-1-60430-135-9

Publication date:
June 2020

Page count:
84


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