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PDF IconRisk Management Series – Article 9:  Risk Management Report

Foreword

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices;  and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know:   508-231-8842.

Introduction

Our last article, Risk Control and Verification (RM8), described the standard approach (i.e., ISO 14971) for identifying appropriate risk controls – following the priorities: inherent safety by design, protective measures, and information for safety. It also, addressed the importance of verification and provided some guidance for determining the most appropriate approach for conducting your verifications. This article describes the Risk Management Report – i.e., summarizing the work that has been done, assessing the overall residual risks, and describing how risks will be managed going forward.