Post-Market Surveillance

Post-Market Surveillance (PMS) is the process of monitoring the safety of a medical device after its release on the market.

Our medical doctors will design, implement, and maintain PMS systems across the spectrum of need in accordance with Article 83 MDR. Whether building a new system from scratch or updating an existing system for the 2021 MDR deadline, we can save you time and money.

Our services include:

  1. Designing your PMS system to make maximum use of your resources and minimise time to implementation.
  2. Developing Vigilance systems in line with Article 87 MDR.
  3. Providing clinical expertise in dealing with medical complaints, making authority reporting decisions and responding to serious incidents.
  4. Writing PMS plans and PSURs in accordance with Annex III MDR.
  5. Designing and implementing clinical investigations and product registries to demonstrate safety and performance throughout the lifetime of a medical device.
  6. Using your PMS system to make improvements to risk management processes and update a product’s Clinical Evaluation.
  7. Using results of PMS to identify needs for any PACAs or FSCAs.

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