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

Date of Event: 
Thursday, April 6, 2017 - 5:30pm to 8:00pm
Location: 
3-111 Keller Hall (200 Union St. SE, Minneapolis, MN 55455)
Map

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

Speaker: David Vogel, Ph.D., Intertech Engineering Associates, Inc.

Presented by the Twin Cities Software Process Improvement Network (Twin-SPIN); sponsored by the University of Minnesota Software Engineering Center (UMSEC)

Cost: Free and open to the public

Parking: Free parking vouchers will be available at the meeting for parking in the Washington Ave. Parking Ramp.

Schedule:
5:30p - Refreshments, and networking
6:15p - Start of Meeting

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:
  1. The difference between device risk management and software risk management
  2. The relationship between risk management and software validation
  3. Dealing with the likelihood of software failure
  4. 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
  1. review the basics,
  2. discuss the above issues,
  3. question whether our current traditional methods result in meaningful risk management activities that really reduce risk
  4. suggest some ideas to improve risk management processes for medical software.

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”.

About Twin-SPIN: The Twin-SPIN software process improvement network (SPIN) is a regional organization established in January of 1996 as a forum for the free and open exchange of software process improvement experiences and ideas. Representatives from industry, government, academia, other professional organizations, and consultants are welcome to participate. Our mission is to help sustain commitment and enhance skills in the area of software process improvement through an active program of networking and mutual support. The organization strives to serve as a source of educational and experiential information for its members, other SPIN organizations, and the general community of software professionals.

Meetings are normally held on the 1st Thursday of each month from 5:45-8:00 p.m. Twin-SPIN is a non-profit organization and is sponsored by the University of Minnesota Center for Software Engineering (UMSEC). See: http://twin-spin.cs.umn.edu
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