Training

MDR Suite | PMS & PMCF

October 14, 2021

Date: 14th of October 2021

Time: 15:00h -17:00h CET 

Location: Virtual

Language: English

Costs: € 395,-

Package deal (package deal): € 3750.-  *

* Team Members with Different Roles & Responsibilities? No problem!
We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package
.

 

Introduction:

Post Market Surveillance (PMS) and its subset of Post Market Clinical Follow-up (PMCF) increasingly become part of the regulatory lifecycle thinking of modern medical device regulations. Moving away from the historic one-time review on compliance prior to market access, PMS needs to be set up as a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.

Post-market surveillance requirements are in direct relation to risks associated with the device based on its intended use, such as the product or technology being new to the manufacturer and the extent of the available scientific knowledge and market experience with similar products.  Actual product-specific plans for gathering post-production data about your product or product family need to be set up for the lifetime of the device.

Regulatory bodies across the globe are imposing increasingly demanding and prescriptive requirements for post-market surveillance. In particular, regulatory bodies are establishing specific requirements for more proactive post market surveillance mechanisms, rather than relying simply on reactive systems, such as complaints monitoring.

Learning objectives:

PMS: 

  • Understand the requirements on PMS in the EU MDR
  • Understand why PMS is important
  • Understand what PMS entitles under the MDR
  • Understand the stakeholders that need to be involved in the PMS activities

PMCF

  • Learn how the scope of PMCF changed from MDD to MDR
  • Learn about appropriate methodologies for PMCF
  • Understand PMCF planning, execution and reporting requirements
  • Understand the role of PMCF in the product life cycle
Wiebe Postma, PhD
Stephanie Valk, MSc.
Post date: March 22, 2021
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