Home Medical Devices Post-Market Surveillance Post-Market Clinical Follow-up (PMCF) plan and report
Post-Market Clinical Follow-up (PMCF) plan and report
In the framework of Post-Market Clinical Follow-up activities, clinical data from the use of a marketed device should be proactively collected and evaluated with the aim of confirming the safety and performance throughout its expected lifetime. This ensures the continued acceptability of the identified risks and helps to detect newly emerging risks based on factual evidence.
- LITERO supports you-in accordance with Annex XIV Part B of the MDR-in the specification of the PMCF methods and procedures for proactively collecting and evaluating clinical data and prepares the PMCF Plan for you.
- In addition, we analyse the findings of the PMCF activities and document the results in a PMCF Report.
- As information gathered through PMCF Report should be used to update any relevant part of technical documentation, in particular Periodic Safety Update Report (PSUR), Risk Management and Clinical Evaluation Report (CER), we will check your documentation and support you in your post-market surveillance and clinical affairs strategies as well as in your process development.