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Traditional Approaches to Risk Management and Medical Device Software Are They Good Enough – Can We Do Better?

Date: 
April 6, 2017
Abstract: 

The details of organizing and executing a risk management process for devices containing software is challenging in a variety of ways. Common questions related to:

  • The difference between device risk management and software risk management
  • The relationship between risk management and software validation
  • Dealing with the likelihood of software failure
  • Managing risk for non-device (820.70 regulated) software

The industry has standards to help with this important process. They clarify many things but leave certain issues uncertain. There are some rational approaches to this that do improve patient and user safety.

In this talk, we will

  • review the basics,
  • discuss the above issues,
  • question whether our current traditional methods result in meaningful risk management activities that really reduce risk
  • suggest some ideas to improve risk management processes for medical software.

Slides - https://www.umsec.umn.edu/events/TwinSPIN-Traditional-Approaches-Risk-Ma...

Directions: 

Directions can be found on the map of the Electrical Engineering/Computer Science Building.
Check out the detailed map by clicking the “close up” button.

Room: 

Keller (EE/CS) 3-111 (Look for signs)

This Month's Meeting
Program Manager: 
Bob Kuczwarskyj
Speakers: 
David Vogel, Ph.D., Intertech Engineering Associates, Inc.
Location: 
University of Minnesota, Keller Hall
Schedule: 

5:30 - 8:00 p.m. at The University of Minnesota
5:30 start for networking, 6:15 start of meeting

Parking: 

Free parking tickets will be handed out in the meeting.

Speaker Bio: 

David Vogel is the founder and president of Intertech Engineering Associates, Inc., of Westwood, Massachusetts. Founded in 1982, Intertech has served the medical device industry by providing medical device development and validation engineering services for a large variety of device manufacturers.

Dave participated with a joint AAMI/FDA workgroup to develop a standard for Critical Device Software Validation which was subsequently included in the IEC 62304 Software Lifecycle Standard. He was also a participant on the joint AAMI/FDA workgroup to develop a Technical Information Report (TIR32:2004) for Medical Device Software Risk Management. Additionally, he worked with the AAMI/FDA workgroup on the development of TIR36:2007 on the Validation of Software for Regulated Processes.

As the author of Medical Device Software: Verification, Validation, and Compliance (2010, Artech Publishing, www.validationtext.com), a frequent speaker at trade events such as the tradeshow conferences, and as an AAMI instructor, Dave has trained thousands of attendees publicly and privately on topics related to product development, validation, design controls, risk management and the development of corporate policies and procedures for device development.

Dr. Vogel received a bachelor’s degree in electrical engineering from Massachusetts Institute of Technology. He earned a master’s degree in bioengineering, a master’s degree in electrical and computer engineering, and a doctorate in bioengineering from the University of Michigan.

Dave has been honored with an Outstanding Achievement Award in Biomedical Engineering from the University of Michigan in 2001, and was named in 2008 as one of MD&DI Magazine’s “100 Notable People in the Medical Device Industry”.