Risks are inherent in software design and development. Identify more risks than you know using Software Failure Mode and Effects Analysis & FMEA.

1. Software FMEA for Medical Devices
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. Instructor Profile:
Dev Raheja, MS,CSP, author of the forthcoming book Preventing Medical Device
Recalls, is an international risk management, patient safety and quality assurance
consultant for medical device, healthcare and aerospace industry for over 25 years.
Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of
Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as
Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for
variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems,
Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.
He has served as Adjunct Professor at the University of Maryland for five years for its
PhD program in Reliability Engineering. He is a Fellow of American Society for Quality
and recipient of its Austin Bonis Award for Reliability Education Advancement and is
Senior Member of IEEE.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

3. 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. 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.
Who can Benefit?
 Senior management
 Software development managers and engineers
 Hardware managers and engineers
 Quality Assurance staff
 Regulatory affairs staff
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. 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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. Live Session - How it works?
• Username and Password will be sent to you 24 hours prior to the webinar
• Presentation handouts in pdf formate will be mailed to you
• Login to the session using the username and password provided to you
• Get answer to your queries through interactive Q&A sessions via chat
• Get certification of attendance.
Recorded Session - How it works?
• A link will be provided to you upon purchase of the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be mailed to you
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

7. Get Connected With Us:
www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com