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.