Risk Management for Software Design in Medical Devices from IEC 62304 and ISO 14971 Perspectives



Pharma IQ News
03/31/2011

NEW YORK, NY AND SAN DIEGO, CA – (BUSINESSWIRE) –Software quality for safety-critical medical devices has been at the centre of discussion for industry experts and especially the FDA. In 2010, 39 of medical device recalls (500 total recalls over the past 7 years) were reported to be related to software defects and malfunctions.  According to an FDA survey, this equates to approximately 8% of device failures.

With an estimated $94.9 billion spent in 2010, the US medical device market is the world’s largest and is highly regulated.  The US Food & Drug Administration has increased their scrutiny, with a strong focus on software and quality.  Medical device manufacturers now find themselves trying to maintain compliance and high quality standards, while dealing with evolving technologies and reducing time-to-market cycles. 

New concepts introduced by IEC 62304 include safety classification for software, testing and risk management, new requirements for software risk management, and updated requirements for ‘SOUP’ product components.  In a recent interview, Thuy Cook, Sr. Software Quality Engineer for Covidien, discussed how to implement these risk management processes for safety critical software using the guidance and best practices from IEC 62304 and ISO 14971. The complete interview with Pharma IQ is available here: Risk Management for Safety Critical Software using IEC62304 and ISO14971 Best Practices

Thuy Cook will be joined by the US Food & Drug Administration, Abbott, St. Jude Medical, GE Healthcare, Boston Scientific, Medical Device Division of Intel Corporationand other leading medical device manufacturers at Pharma IQ’s 14th Annual Software Design for Medical Devices to discuss the top concerns and challenges of this industry. The event, being held May 23-25, 2011 at the Hilton San Diego Resort and Spa in San Diego, CA will assist medical device manufacturers decrease their medical device development cycle time, while ensuring product safety and integrity.

Specific topics for discussion at the event include: 

  • Develop & implement quality project management processes in your organization
  • Stay up to date with the shifting picture of software compliance
  • Achieve medical device innovation through progressive design & engineering strategies
  • Integrate human factors engineering into medical devices to make them safe, effective and efficient to use
  • Insights from hardware engineers onbattery life and power in relations to software design and development

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For more information on the 14th Annual Software Design for Medical Devices, please visit www.SDMDConference.com or contact Claudia Rubino, Program Director at Claudia.Rubino@iqpc.com.  

About IQPC
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