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01.07.2020 00:00

FDAnews Announces -- EU-MDR Postmarket Surveillance: Best Practices for Medical Device Regulatory, Compliance & Quality Specialists Webinar, July 14, 2020

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FALLS CHURCH, Va., June 30, 2020 /PRNewswire-PRWeb/ -- EU-MDR Postmarket Surveillance:
Best Practices for Medical Device Regulatory, Compliance & Quality Specialists
An FDAnews Webinar
Tuesday, July 14, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/eumdrpostmarket

Prepare for EU-MDR postmarket surveillance (PMS) requirements and its detailed product-specific plans and reports.

With greater emphasis on confirming safety and performance throughout a device's lifetime, one needs to be more proactive with one's postmarket activities than before, including the postmarket clinical follow-up (PMCF).

Plus, to ensure alignment, all the data collected needs to be considered in a clinical evaluation report (CER), risk management documents and labeling. Learn to do this with maximum efficiency.

Jon Gimbel, Ph.D., will explain the best practices needed to easily create — and keep up to date — product-specific plans and reports to stay compliant. He'll explain how these activities are all related, enabling one to improve efficiency throughout the organization:

  • Details on the specific data elements that should be included in the Postmarket Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), PMCF report and CER and how the data from various reports can be linked together.
  • An overview of an example process that will enable the PMS, PMCF, CER and risks management documentation to be linked and updated together.
  • An explanation of how proactive PMS is related to PMS and PMCF and what type of activities are considered PMS vs. PMCF.
  • An understanding of the type of objectives of PMCF, such as to confirm safety and performance throughout the lifetime of the device and not to provide sufficient clinical evidence to demonstrate conformity to the applicable General Safety Performance Requirements (GSPRs).
  • A discussion of common findings related to PMS and PMCF, such as failure to provide a statistically justified sample size.

Easily master postmarket surveillance and confirm the safety and performance throughout the lifetime of one's medical device. Be ready by the May 2021 deadline

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
EU-MDR Postmarket Surveillance:
Best Practices for Medical Device Regulatory, Compliance & Quality Specialists
An FDAnews Webinar
Tuesday, July 14, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/eumdrpostmarket

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/eumdrpostmarket
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

 

SOURCE FDAnews

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