Post Market Surveillance (PMS) plan

What is a Post Market Surveillance (PMS) system and plan?

As a medical device manufacturer, you must have a PMS system that is suited to actively and systematically gather, record and analyse data related to quality, performance and safety of your device upon marketing and throughout its entire lifetime. The PMS system must be integrated in your Quality Management System (QMS). It will, amongst other, be needed to determine, implement and monitor any corrective and preventive actions (CAPAs) as well as field safety corrective actions (FSCAs).

The PMS system shall be based on a PMS plan, which must be included in the technical documentation for your device (except for custom-made devices). The PMS plan shall describe the proactive and systematic process that you use to collect the following information (non-exhaustive) for your device:

Serious incidents and FSCAs
Non-serious incidents and undesirable side-effects
Trend reporting
Relevant specialist or technical literature, databases and/or registers
Feedback and complaints from users, distributors and importers
Publicly available information about similar medical devices (including a comparison with your device)

Moreover, it shall include methods and protocols about how to identify and manage incidents. The PMS plan should also include a post market clinical follow-up (PMCF) plan, when applicable.

AML Christensen’s service

At AML Christensen, we know how to develop PMS plans that comply with the requirements of the MDR / IVDR. As such, we are happy to help you create a PMS plan for your device. The PMS plan will be developed in a fashion that aligns with your PMS system and Standard Operating Procedure (SOP).

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Post Market Surveillance (PMS) plan

What is a Post Market Surveillance (PMS) system and plan?

AML Christensen’s service

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