We have spent a couple of videos looking at safety reporting, to better understand it’s role in the MDR, the Medical Device Regulation.
Today, we’re going to tackle a broader question that also encompasses everything we’ve been talking about with safety reporting:
How is risk management related to the ISO14155?
As we discussed in one of our earlier articles on clinical evaluation, there are many processes to go through to make sure that a medical device is safe and performs as indicated throughout the lifecycle of the device.
But how are they related and why is it important?
The application of ISO14971 – in other words, risk assessment – to clinical investigations is described in detail in Annex H of the ISO14155.
The application of risk management activities within a clinical investigation helps hazards and hazardous situations associated with the medical device to be identified and minimized from planning till closure of your clinical investigation.