Introduction

During device discussions it became evident that the risk assessment framework did not fully capture some of the issue we had highlighted. Furthermore, we highlighted that there was a lack of cohesion between pre- and post-market risk analysis.

Aim

To assist the regulatory affairs officer in creating a new company-wide risk assessment algorithm.

Method

We took five years of risk and complaint data to analyse and categorise trends into clinically relevant segments of address. We cross-referenced these segments to published data to part-validate and explore the real-world outcomes. Using the regulatory frameworks for risk assessment, a new system of classification was developed both for pre-market analysis and post-market surveillance.

Conclusion

The regulatory department have fully integrated the risk analysis framework and have used it to inform their approach to MDR requirements, authority feedback from complaints and concerns, and to isolate points of company focus to enhance process efficiency and reduce cost.