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Risk Management (n.) | hazard…

A good risk management process is, in fact, insurance. It identifies and addresses product risks and hazards at each stage of the product development process (PDP), ensuring they don’t become liabilities later on. But knowing which analysis techniques to use, when to use them, and how to document it all, can be challenging. Does your PDP require an FTA, dFMECA, uFMECA, or pFMECA? How do you define “misuse” for your specific device? Do your risk scores relate to your product’s actual safety? What are the best ways to mitigate risk? Are you testing more samples than you need and wasting money? And what about the time wasted in ineffective hazard analysis meetings that seem to go on for days?

…insurance

Risk management doesn’t have to be a mystery. It just requires some education and training. For example, Preliminary Hazard Analysis is used throughout (and best used early in) the development phase to identify potential hazards. FTAs (Fault Tree Analysis), FMEAs (Failure Mode and Effect Analysis) or FMECAs (Failure Mode and Effect Criticality Analysis) are used in several phases of the process, such as design (dFMECA) and process (pFMECA). A comprehensive risk management process should be integrated with your quality management system—it can even guide some activities, such as CAPA, verification and validation.

Whether you need clear SOPs to walk you through the process, training for you and your teams, a leader to keep meetings on track, or just need to demystify the process, AlvaMed can provide the customized help that fits your unique needs. We invite you to contact us for answers to your questions (we may even ask you a few of our own). Learn more about AlvaMed and how we can help ensure your pathway is hazard-free.

Click here to begin a conversation or call 781-710-2418.

Email us at info@alvamed.com.

Learn more about:
Medical Device Quality Assurance
Design Control
Quality Systems
Verification
Validation

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