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. 

 

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