avaPMCF

The clinical evaluation must be regularly supplemented with new clinical data as part of market surveillance (post-market clinical follow-up, PMCF). In doing so, requirements from European laws and guidelines must be considered, which are tested by Notified Bodies.

With avaPMCF we provide you with templates for PMCF Plan and PMCF Evaluation Report as an extension to avaClinical, which are based on the requirements of MDCG Guidelines 2020-7/2020-8. The digital documentation makes it easy to reuse existing information from input documents, thus reducing the time and effort required to create them.

A central overview of planned PMCF activities in the company and a time monitoring system combined with email notifications ensure that no activity is forgotten. Results from PMCF activities are also centrally documented and managed. Customizable tables provide a user-friendly overview of information and results are automatically inserted into the corresponding PMCF evaluation report, thus minimizing manual effort. Information from the PMCF Evaluation Report can be reused in the Clinical Evaluation Report as well as in the PMS Report or Periodic Safety Update Report (PSUR), thus reducing the time and effort required to create and update the PMCF Evaluation Report.

Linking PMCF information to content in the Clinical Evaluation Report and the Risk Management File illustrates the interdependency of information, allowing you to quickly see the impact of PMCF results on other elements of the Technical Documents.