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Using Dynamic Software Analysis to Support Medical Device Approval

November 2012
12 pages
Using Dynamic Software Analysis to Support Medical Device Approval

Two key challenges facing medical device software manufacurer are a) demonstrating safety and b) obtaining approval by regulatory agencies. In this paper we look at how dynamic code analysis can support demonstrations of compliance with safety requirements, and key capabilities to look for in dynamic analysis tools. We conclude with tables mapping development activities with requirements in the IEC 62304 standard, and a short description of important OS characteristics.


Demonstrating dependability — IEC 62304 — Dynamic analysis — Choosing a software analysis tool — Conclusion — Appendix A: IEC 62304 and development activities — Appendix B: the operating system [+]

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Mark Pitchford

Mark Pitchford

Mark Pitchford has over 25 years’ experience in software development for engineering applications. He has worked on many significant industrial and commercial projects in development and management, both in the UK and internationally including extended periods in Canada and Australia. Since 2001, he has specialised in software test, and works throughout Europe and beyond as a Field Applications Engineer with LDRA Ltd.

Mark studied at Nottingham Trent University and has been a Chartered Engineer for over 20 years. He has published numerous articles on software validation, the use of SOUP (software of unknown pedigree) in safe systems, and standards such as ISO 26262.

Chris Ault

Chris Ault

Chris Ault is the senior product manager responsible for QNX Software Systems’ medical software portfolio, including an Operating System compliant with the IEC 62304 standard. Recognized for his software expertise, Chris has written articles for Electronic Design, Embedded Intel Solutions, and Design & Elektronik and presented at events such as the Medical Devices Summit, mHealth, Embedded World, and the Embedded Systems Conference.

Before joining QNX, Chris was a senior product manager focused on virtualization technologies. He has held positions of increasing responsibility with hardware and software vendors, including Ciena, Nortel, Catena Networks, and Liquid Computing.

Chris holds degrees in computer science, electronics, and economics from Algonquin College and Carleton University.

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