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Newsletter V. 2019 Issue 3

Risk Management

Risk management plays a central role in medical device development but many medical device professionals I’ve worked with over the years seem to have missed the forest for the trees.  They are more focused on the details of risk management compliance than the central goal of product safety. This blog post summarizes the key lessons I’ve learned about keeping your eyes on The Big Picture for Medical Device Risk Management.   

Additional Risk Management Resources

These are links to information on risk management by some very experienced and knowledgeable consultants who write in clear, concise terms that make this complex subject more understandable:

  • Rob Packard has an excellent summary of the latest changes to the ISO 14971 Risk Management standard in his Medical Device Academy blog: ISO 14971 Risk Management Updates (OCT 2018)
  • Sam Lazzara created this flowchart in his Medical Device Quality Cloud to align with the European version of 14971: EN ISO 14971:2012 Risk Management Flow Chart  (MAR 2017)
  • This webinar by Emergo provides a good general overview of the ISO 14971 Risk Management standard, the way it serves as a ‘backbone’ to other standards, and a broader view of risk management throughout the company: Risk Management Landscape (APR 2018)
  • Tom Shoup has written an excellent text on Risk Management for Medical Devices which is available through the AAMI website: Premarket Risk Management
  • Also, this webinar on Dynamic Risk Management I presented with some software experts shows how to leverage software tools to implement a flexible and rigorous process for risk management that can keep up with fast moving development teams and rapid design iterations.

Upcoming Events

Have employees new to medical devices? 

I offer practical training on Medical Device Design Controls either on site or at a public workshop. 

Happy to help.

Navigate through rigorous regulatory compliance

About Sunstone Pilot 

Sunstone Pilot provides consulting services to medical device development teams to help them efficiently comply with regulatory requirements for hardware and software development: risk management, requirements management, V&V testing, and other design controls.

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