A Regulatory Guide to Post-Market Surveillance What's New

A Regulatory Guide to Post-Market Surveillance

Posted on by Congenius

Post-Market Surveillance (PMS) according to MDR 2017/745 and IVDR 2017/746 is a systematic process to continuously monitor the safety and effectiveness of a medical device after it has been launched on the market. This is done by collecting information and deriving necessary corrective and preventive actions.

For MedTech companies engaging with the topic for the first time, or those with limited experience in managing post-market data, the costs and complexity of comprehensive PMS activities pose a significant challenge. This highlights the necessity for specialised knowledge in the development and execution of effective post-market surveillance strategies.

Brought to you by our Head of Regulatory Bruno Gretler, the whitepaper below provides an overview of the objectives and procedures of post-market surveillance (PMS) for medical devices, conducted in collaboration between manufacturers and their economic operators.

The purpose of the whitepaper is to highlight the essential steps to ensure continuous compliance with safety, quality, and performance requirements after medical devices have been launched on the market.

Specifically, the free whitepaper below covers:

  • What is Post-Market Surveillance?
  • What are the related regulatory requirements in the EU & US?
  • What are the fundamentals of Post-Market Surveillance?
  • What are the challenges involved in implementing & maintaining an effective PMS system?
  • How can companies overcome the challenges arising from PMS requirements?

You can access the full whitepaper at the download button below.

Can’t see the whitepaper? Simply log in, or subscribe to our Knowledge update for full access to all content from our MedTech experts.

To discover more about our Regulatory services, see here, and should you have a PMS-related challenge, please do get in touch.

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