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Thursday, September 18, 2014
10:00 AM - 11:00 AM
10:00 AM - 11:00 AM See all dates and Times
http://complianzworld.com/Webinars.aspx?TopicId=496&Sub=Failure-Mode-and-Effects-Analysis-for-Software-in-Medical-Devices
Description: It's not enough to do your best. You must first know what to do, and then do your best. The FMEA methodology is so structured; it forces you to identify the right things to do. One of the right things to do is to not repeat the failures in the old software designs into the new devices. Why companies are prone to having past problems in new devices? One of the main reasons seems to be the 'weak cognition.
Course Objective:
The ISO 14971 and its risk analysis tool FMEA has been recognized by FDA, and in Europe, for risk mitigation of medical devices. Compliance with ISO 14971 will therefore be crucial not in meeting regulatory requirements but also as a most important part of design control. The FDA reviews the results of the FMEA as preview to device recalls, during adverse event analysis, and complaint investigations. FMEA may be very difficult and tedious for the case of complex systems which have multiple functions consisting of a millions of lines of code.
Course Outline:
• Software FMEA fundamentals
• Frequent mistakes in FMEA
• Different levels for FMEA
• System Functions FMEA
• Subsystem level FMEA
• Module level FMEA
• Code level FMEA
• Interface FMEA
• Severity rating scale
Target Audience:
• Software Managers
• Software Developers
• Hardware Engineers and Managers
• System Engineers
• Quality Engineers
• Quality Auditors
Speaker profile : Dev Raheja
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare.
Event price tags :
$ 229.00 Single Attendee
$ 749.00 Group – Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
For More Details or Enrollment Or Registration :
Contact : complianzworld
Phone : +1-866-978-0800
Fax : +1-888-883-7697
Course Objective:
The ISO 14971 and its risk analysis tool FMEA has been recognized by FDA, and in Europe, for risk mitigation of medical devices. Compliance with ISO 14971 will therefore be crucial not in meeting regulatory requirements but also as a most important part of design control. The FDA reviews the results of the FMEA as preview to device recalls, during adverse event analysis, and complaint investigations. FMEA may be very difficult and tedious for the case of complex systems which have multiple functions consisting of a millions of lines of code.
Course Outline:
• Software FMEA fundamentals
• Frequent mistakes in FMEA
• Different levels for FMEA
• System Functions FMEA
• Subsystem level FMEA
• Module level FMEA
• Code level FMEA
• Interface FMEA
• Severity rating scale
Target Audience:
• Software Managers
• Software Developers
• Hardware Engineers and Managers
• System Engineers
• Quality Engineers
• Quality Auditors
Speaker profile : Dev Raheja
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare.
Event price tags :
$ 229.00 Single Attendee
$ 749.00 Group – Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
For More Details or Enrollment Or Registration :
Contact : complianzworld
Phone : +1-866-978-0800
Fax : +1-888-883-7697
