Video FAQs

The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task. How should the data flow and where does it start?

The video FAQ provides a helpful graphic along with our subject matter experts describing the cross-functional integration of the QMS and how the data flows between PMS, PMCF, and clinical activities, Where do we start? It looks straight forward - you have a new product with claims and a risk analysis, flowing into a CER, which flows into a PMCF plan and then data from PMS and PMCF activities flow back to the risk analysis which gets updated. However, rather than being a smooth wheel like what was just described, it's more like a wheel with eddies in it, or cycles within a cycle, and that's expected. The important thing is having a procedure and document control system that shows how you're managing all of these inputs and changes.