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?
Transcript:
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.
