|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
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
- What are the key regulations, standards and guidance