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Technical documentation of medical devices and IVDs

Supporting PMS activities

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Supporting PMS activities

Post-Market Surveillance (PMS) activities are more than just a legal requirement as they are essential for ensuring a high level of health and safety protection for patients and users to be guaranteed and maintained overtime. PMS can also unlock valuable insights and opportunities for your business:

We will assist the company’s staff in reviewing the existing PMS procedure, preparing PMS plans and reports, and/or in the ad hoc planning of different post-market surveillance actions that will be designed with multiple purposes, depending on the specific company reality and the peculiarities of the device. Our PMS activity support service is modular and is aimed at companies that need to comply with the obligations of EU Regulations 2017/745 and 746 and at the same time wish to optimize their investment through properly planned and implemented actions.

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