Software FMEA for Medical Devices

FREMONT, Calif. - Dec. 18, 2014 - PRLog -- 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:
The objectives of the Presentation are to talk about topics covering:
ISO 1491 requirements for FMEA
How can we apply FMEA to software design?
Levels of Software FMEA
System Functions Software FMEA
Software Functions FMEA
Identifying failure modes
Predicting causes of system failure
Risk analysis techniques
Developing risk acceptance criteria
Risk mitigation strategies
Mitigating risks to patients by designing for prognostics
Code level FMEA
FDA requirements for document control
Role of management in risk monitoring

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

Contact:
Toll free: ‎+1-510-857-5896‎
Email: webinar@onlinecompliancepanel.com
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA
Use For Registration: http://www.onlinecompliancepanel.com/ecommerce/webinar/~B...