Module 16 2022

05/09/2022

Hazard analysis

Risk reduction measures verified

Severity becomes clearer due to involvement of clinical specialists and more knowledge

Able to evaluate the severity of harm if available data relates to a similar device or characteristic

Cannot estimate how likely it is to occur but can at least foresee hazards and from evaluation of data know potential frequencies

Estimates made based upon the strength of your control. Coupled with verification you should now be able to predict the likelihood of occurrence

about your design and intended use

Post market surveillance plan

Considers the risks, residual risks and the quantitative assessments about likelihood and severity. The data and sources are established to inform the PMCF and PSUR

Risk 1

Probability = 1 in 10,000

PMS Plan

Time

Post-market surveillance system

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Aspect

Source

The process that gets this data

WHO + Process owners Methods to assess and collect the data Which functions access, collect and compile this data

Indicators and threshold values for action -

What to look for

Serious incidents

What system or data repository shall retain this data

Which Internal or external process will provide the data

What will trigger vigilance or corrective / preventive or FSCA?

Are the specific search strategies / survey tools or data to look out for

Typically Benefit / Risk ratio

Non-serious incidents / side effects Information from trending Specialist literature, databases and / or registers Feedback data Public information similar devices

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