Module 16 2022

05/09/2022

 Statistically significant increase in the frequency or severity of incidents  Not serious incidents  Expected undesirable side-effects that could impact the benefit-risk analysis  Significant increase is compared against the foreseeable frequency and severity assigned in the residual risk.

The Organisation for Professionals in Regulatory Affairs

39

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

The Organisation for Professionals in Regulatory Affairs

40