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Software FMEA for Medical Devices Webinar  

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Seminar Summary:

Risks are inherent in software design and development. Identify more risks than you know using Software Failure Mode and Effects Analysis FMEA. (see full course description)

 

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Training Course Syllabus:


Software FMEA for Medical Devices Webinar

Time: 11:30 AM PDT | 02:30 PM EDT

Duration: 90 Minutes

Instructor: Mike Morley


Description:

Software related device recalls are steadily going up for the last 10 years. The biggest reason is that missing and vague requirements in software specifications are responsible for at least 50% failures. Therefore risks are inherent in software design and development, even after so much attention paid to the design control process. You can identify more risks than you know if you use the Software Failure Mode and Effects Analysis (FMEA). This tool predicts many life cycle failures; assess risk of each failure, and helps design out risks by using the best practices in risk mitigation strategies. Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.

Why Should you Attend:

Understanding system failures in advance and evidence based best software practices is a profound knowledge. This webinar is conducted by the international risk management consultant with over 30 years experience and the author of the text Preventing Medical Device Recalls.

Objectives of the Presentation:

This training on Credit Card Program Benchmarking will cover the following areas:


  • ISO 14971 requirements for FMEA

  • Difference between software FMEA and hardware FMEA

  • How can we apply FMEA to software design?

  • FMEA at several levels of software

  • Predicting software malfunctions and failures

  • Applying risk acceptance criteria

  • Failure avoidance strategies

  • FDA requirements for software design control

  • Role of management in software design


Who can Benefit:


  • Senior Management

  • Software Development Managers and Engineers

  • Hardware Managers and Engineers

  • Quality Assurance Staff

  • Regulatory Affairs Staff

  • Service Engineering Managers and Engineers



Seminar Summary:

Risks are inherent in software design and development. Identify more risks than you know using Software Failure Mode and Effects Analysis FMEA. (see full course description)

print this agenda print agenda for the Software FMEA for Medical Devices Webinar training seminar

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