Post Market Surveillance Plan - ISO 13485

ISO 13485 - QMS.4.2.3.1.7 - Device Post Market Surveillance Plan Template

The medical device regulations EU 2017/745 require the manufacturer to have in place a post market surveillance plan as part of the post market surveillance requirements. This plan details the actions a manufacturer will take once their medical device has been placed onto the market. This PMS plan covers the requirements of the medical device regulations (EU 2017/745).

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