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White Paper

Improving Medical Device Risk Management

Medical device product development has been a foundational element of the practice and betterment of medicine for about as long as mankind has been trying to heal people. Over the millennia, our medical devices have become more complex and powerful, and the same can be said for the regulatory environment.

Tools used for the purpose of tracking complexity are too simplistic when it comes to compliance and traceability. Traditionally, one of the more difficult system development tasks faced by developers is the challenge of implementing effective medical device risk management. This white paper investigates some of the challenges of medical device risk management and how to improve the process.

Benefits of an effective medical device risk management strategy

Medical device risk management needs to be a living process that becomes a granular part of the entire product development process. Many of the challenges around risk management comes from using old technology – static written documents and spreadsheets – to track the complex and dynamic environment. By using Siemens Digital Industries Software’s solution for medical devices, teams can easily track and report against whatever risk management information is required.

Optimizing traceability in medical device risk management

Traceability is the foundation of medical device risk management. Organizations need the ability to precisely trace interrelated work items and their relations to design and regulatory requirements, test cases, V&V processes, build controls, hazards, harms and mitigations. To optimize traceability, teams must adopt an efficient solution for managing product requirements. A robust requirements management solution can support workflows and traceability through the design manufacturing and risk management relationships.

Importance of implementing a solid risk management model

Detailed tracking and traceability are required for the documentation and mitigation of hazardous situations to control outcomes and ensure that a medical device is predictable and safe. A well-designed, comprehensive risk management tool should be able to support a risk management data model that ensures consistent use of definitions, work items and workflows to identify and mitigate harms and hazards. A risk management data model brings precision to your operations and allows you to set definitions and enforce consistency.

Defining essential documents for medical device risk management

Definitions are essential throughout the process of medical device risk management. The risk management plan, risk analysis and risk management report are all items that require a specific structure and specific contents, as defined by EN ISO 14971:2009. The risk management plan should include scope of activities, assignment of responsibilities and more. Risk analysis documents must take a harms-based approach. And the risk management report should ensure that the overall residual risk is acceptable.