Intertech Engineering Associates, Inc.

Intertech Industry Webinars

Using Risk Management Results to Organize Validation Efforts for Medical Device Software

Webinar Speakers: David A. Vogel, Ph.D., Intertech Engineering Associates, Inc.
Robert E. Barrett, Intertech Engineering Associates, Inc.

Workshop Duration: 1 hour (includes 10 min for Q&A)

This course is intended for software engineering, quality, and regulatory compliance professionals who are responsible for risk management, hazard analysis, and/or validation of software that is embedded in a regulated medical device, or is itself considered a medical device.

The topics of this workshop include:

  • The growing role of risk management in software validation
  • Software Risk Management: Is it Different from System Risk Management?
  • Is FMEA the same as Risk Management?
  • Documenting your Risk Management efforts
  • Have you covered your risks?
  • How to use risk management to focus validation efforts where they produce the most results, not the most paper.
  • How to determine how much testing is enough. Are you testing enough? Are you testing the right things?
  • How to use risk analysis when making software changes to an existing product
  • Types of software testing, including system level, integration level, unit level, ad hoc, regression, automated, and session based testing. Understanding how each type of testing addresses risk validate a device.

This is a high level, fast paced webinar that covers key concepts in risk management, medical device software validation, and how the two relate.

Click here to access an audio-visual recording of the webinar. You will be asked to register to listen to the webinar, but there is no cost to do so.

Click here to access a transcription of the Questions and Answers.

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