PMS activities not only enable compliance with a legal obligation and allow a high level of health and safety protection for patients and users to be guaranteed and maintained, but can also be useful for:
- Discovering unforeseen performances that can become the starting point for new development projects
- Having up-to-date data with which to renew commercial material
- Collecting data that, when passed on to the doctors using the device, highlight its specific characteristics
- Collecting information that, if conveyed to patients, can increase their awareness and confidence in using the device
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 corporate reality and the peculiarities of the device.
Our PMS 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 optimise their investment through properly planned and implemented actions.