Risk analysis is a search of hazards and an assessment of possibilities and severities resulting damages.
The aim of risk analysis is to identify risks. Usually medical device manufacturers act in the following way in terms of risk analysis:
1. Search for hazards. For this, following risks analysis applies
2. Estimate the probabilities and severities of the resulting damages (and therefore the risks)
3. Decide on the approval of those risks (see risk acceptance)
Our tips regarding risk analysis for software are in form of a large scale of information that we decided to put it together in an article. Read more about it here.
The following errors in the risk analysis result in problems continuously arising in the audit or the filing of the technical documentation:
The ISO 14971 requires that the personnel responsible for the risk management staff has the necessary qualifications.
Just what are they? The IEC 80002 gives us a few pointers:
I can only agree with these estimations. But I would go one step further: The risk management does not belong in the hands of the development department. The risk manager must be an independent person who has mastered the process and has "orchestrated" doctors, users and developers during the building of the risk management file