Fast Tracked PMCF Activities
May 16, 2023
This case study looks at fast tracked PMCF activities and how CLIN-r+ supported one manufacturer with their Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence.
Category: Post Market Clinical Follow-up
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You Got CE Marked – What’s Next for your Medical Device?
April 18, 2023
The CE mark is a major milestone for most medical devices. It can take a long time to obtain and be a challenging process. CLIN-r+ looks at the manufacturer responsibilities once the CE mark has been granted, update requirements, and more.
Post Market Clinical Follow up (PMCF)
April 8, 2023
The EU MDR increases the need for Post Market Surveillance (PMS), and therefore Post Market Clinical Follow up (PMCF). CLIN-r+ explains how manufacturers will need to collect more clinical evidence and improve data quality and management for each device.
Clinical Investigations for Medical Devices and IVD
March 15, 2023
Clin-r+ outlines the requirements and considerations manufacturers should review to ensure that Clinical Investigations they undertake are well researched to ensure a return on investment.
Three Tips for PMCF Planning
February 25, 2022
The EU MDR has raised the bar for supporting data quantity and quality, so it is critical to keep the pace of preparation activities in Post-Market Clinical Follow-Up planning. This document provides manufacturers with best practice guidance for preparation, steps, and the three key pitfalls which CLIN-r+ frequently encounters.
