PMCF Plan Template & Procedure

Post Market Clinical Follow Up (PMCF) as per MDR article 83 is hard to understand, so preparation of fully complying PMCF procedures and templates is hard for newcomers as well those who has less time to spend in research.

As per MEDDEV 2.12-2 rev 2,and MDR Annex XIV Part B paragraph 6.2, each device PMCF study should have well defined plan describing the design and methodologies for proactive clinical data collection to ensure that safety, performance, user feedback, and clinical experiences. Its really hard for getting all the elements of the PMCF in right way, so use our ready and customizable procedure and templates. Our experts spend time and effort to develop procedures and PMCF plan template suitable for buyers to edit and use. Interested parties can write to us or purchase directly from the I3CGlobal website.