A Post Market Surveillance Plan comprises a systematic approach to continuously monitor the safety and performance of medical devices available in the market. It entails a well-defined strategy for gathering data directly related to the risks associated with the medical device’s intended use.
The significance of the Post Market Surveillance Plan lies in its ability to outline the requirements for conducting PMS activities. This plan is mandatory for all devices, excluding custom-made ones, and should be included in the Technical Documentation. It encompasses various aspects, such as:
Suppose you’re interested in obtaining a Post Market Surveillance Plan. In that case, we offer PMS Plan Templates and Standard Operating Procedures (SOP) that comply with EN ISO 13485:2016, Section 8.2.1, and the Meddev NB-MED/2.12/Rec.1 guideline. These templates will assist you in preparing the Medical Device CE Marking and MDR Technical File, with the PMS Procedure/SOP, Plan, and Report, along with its conclusion, forming an integral part of the process.
To effectively conduct PMS planning, the following steps are recommended: