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post-market clinical follow-up
The post-market clinical follow-up (PMCF) is a continuous process for updating the clinical evaluation report and that shall be one of the outcomes of the manufacturer’s post-market surveillance (PMS) plan. A PMCF plan shall specify proactive methods and procedures for collecting and evaluating new clinical data from the use of a medical device once placed on the market or put into service within its intended purpose. According to the requirements for developing a PMCF Plan defined in Annex XIV of Regulation (EU) 2017/745, Cebis implement a PMCF taking into consideration the device itself and the existing clinical evidence with literature search, case reports, survey or clinical investigation.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
