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Risk Management in Medical Device Manufacturing

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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.

In this webinar are discussed tips on implementing and improving the risk management process in medical device companies. Further, it is addressed the way in which robust behavioral modeling can be integrated with downstream risk management practices to support better and faster production. 

Key takeaways

  • 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

Recorded webinar

"Risk Management in Medical Device Manufacturing

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.