Editor's Note: A German version of this article, " Verbesserung des Risikomanagements für Medizinprodukte - Whitepaper," is available here.
Over the millennia our medical devices have become more complex and powerful, and the same can be said for the regulatory environment. Regulations are essential as they help to ensure that medical devices are designed with verification and validation (V&V) so they comply with required specifications and can be used for their intended clinical purposes.
Conceptually, risk management seems simple enough. Given that potentially hazardous situations can lead to harm, these potentially hazardous situations must be documented and mitigated to control outcomes and ensure that a device can be used predictably and safely.
However, as everyone working with compliance knows, things can get complex in a hurry, especially when dealing with multiple regulations, conflicting definitions and the need to track compliance at a digital level. This complexity is caused by a variety of factors, including the number of variables needed to describe the relationships between system components, options for whether to make these concepts unique or re-usable, the many-to-many relationships required to track compliance, and sometimes vague or confusing regulatory expectations.
Tools currently used for the purpose of tracking complexity are not just simple, but simplistic. Although spreadsheets are good for tracking one-to-one relationships, they quickly become far less useful when dealing with the one-to-many and many-to-many relationship tracking required for ensuring regulatory compliance for medical device product development.
Spreadsheets and Microsoft® Word software documents are not really meant for the essential task of achieving traceability. Traceability is at the heart of quality control during the design and development stage, and continues to be essential post release when linking surveillance reports back to specific product requirements and V&V processes.
Siemens PLM Software provides a powerful solution for medical device product development.
White Paper: Improving medical device risk management This white paper investigates some of the classic challenges of medical device risk management and demonstrates how using Siemens PLM Software’s solution significantly improves the process. It provides a robust repository and workflow management solution that simplifies tasks such as requirements management and reporting, while automating deep traceability.