Risk Management in Medical Device Manufacturing
Medical device manufacturers operate in an increasingly regulated, safety-critical environment, and frequently have many variants of parts, products and product lines. It is, therefore, necessary to identify, estimate and evaluate your device risks at the right time to increase the quality and safety of the device, and to motivate the project members.
Having an effective risk management process adds value by decreasing the project risks and avoiding costly late-stage changes. There are several aspects of implementing an effective risk management process. A recommended first step would be to establish a risk management process including usable and operational templates so that the process complies with ISO 14971:2012 for the European market and ISO 14971:2007 for the rest of the world.
This Free webinar will provide you with some tips on implementing and improving the risk management process. It will address the way in which robust system behavioral modeling can be integrated with downstream risk management practices to produce better and safer products.
Participants will learn
- How to improve efficiency in controlling and managing complex data structures
- How to secure and improve traceability
- How to improve visibility and processes
- How to secure a complete audit trail in one system
Business of Engineering and Medical Device
Interested in the Business of Engineering in medical device manufacturing?
Read more about how integrating MBSE and PLM can enable medical device organizations to excel at verifying the behavior and design of their systems.