PMCF Data Quality Challenges & Best Practices

Health Authorities and Notified Bodies are regularly stressing more on safety and in such situations Post-Market Clinical Follow-up (PMCF) becomes necessary. To conduct PMCF and ensure the safety of the medical devices, it is highly suggested that you know the challenges that might come to the surface with regards to data quality. This paper would close with the challenges alone but will also provide the best practices which if implemented, can potentially yield necessary results during the process of conducting PMCF.

Key Elements to Look Out For:
In Challenges

• Human Errors
• Study Deviations
• Data Quality Definition

In Solutions

• The Purpose
• Impact of Digitization
• Data Quality Definition