Medical Device Software and Risk Management - Webinar Recording/Transcript

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Medical Device Software and Risk Management

FDA’s QSR section on design validation has two interlocking requirements. One requires software validation and the other requires risk management. Interesting issues arise when both apply to the same medical device. And while ISO 13485:2016 doesn’t have an explicit reference to software in a medical device, the same issues apply there too.

It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. That’s why FDAnews has reached out to Dan O’Leary, our go-to expert on medical device compliance, to simplify a knotty area of FDA and international device regulation.

Over the course of 90 minutes, Mr. O’Leary will break complex compliance issues down into simple English. Get ready for mastery of:

  • FDA-CDRH guidance documents related to software
  • Interrelationships among software development, pre-market submissions and post-market activities
  • Determining the Level of Concern for a software device
  • ISO 14971:2007: Understanding its role as the overarching risk management document
  • IEC 62304:2006 & A1:2016 and its role as a software process standard
  • The Software Safety Classof a medical device and how to determine it
  • IEC/TR 80002-1:2009: How to use it
  • And MUCH more!

FREE Bonus Material! Participants receive an Excel workbook that helps determine a) the Level of Concern and required documentation and b) the Software Safety Class and associated process steps.

Medical device risk management — specifically device software risk management — calls for a solid understanding of the documentation framework. This can be challenging because it includes elements from both the FDA view and the international standards view. It’s technical, sure … but all the more reason you must get it right. Here’s the moment to do just that.

Software development and risk management are best accomplished through a team. Team members who ought to consider attending include:

  • Software managers and engineers
  • Software quality specialists
  • Risk managers
  • Cybersecurity specialists
  • Regulatory submission managers and specialists

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.