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With product withdrawals on the increase, regulatory agencies are placing greater emphasis on Post Market Surveillance (PMS) as a way to improve risk management.

A successful post market surveillance strategy will ensure that the risk to patients and the number of unforeseen adverse events from device failure are minimized, and will help device and diagnostics companies avoid the litigious minefield that has been highlighted recently by high-profile implant class actions.

Once a medical device has been approved for supply it is necessary to make sure that the product continues to meet all the regulatory, safety and performance requirements and standards that were required for the approval. This is in addition to ensuring that any problems with the product are dealt with and reported through appropriate channels.

This post market phase for a medical device is as important as all of the pre-approval activities. Prinsip Mahir's Post Market Surveillance Programme provides insight into how companies can develop and improve their own post market surveillance systems.

Key questions: -

  • What is post market surveillance?
  • What factors must medical device and diagnostic manufacturers consider when setting up their post market surveillance programme?
  • What are the key regulations, standards and guidance documents?


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