Software Risk Analysis Tools for Medical Devices and Risk Mitigation at Chicago

Overview:

The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification 

Why should you attend?

You have to do risk analysis using the tools in ISO 14971. It is one of the first things FDA will ask for! It is required by law (21 CFR Section 820) and appears on regulatory submission checklists. In addition, it will help define validation that should be done to prove the safety of your actual device use. You can also eliminate costs associated with recalls and lawsuits.

Areas Covered in the:

• Overview of ISO 14971
• Overview of IEC 63204
• The best tools for risk analysis
• Application of tools such as PHA,FMEA,FTA
• Identifying missing requirements in specifications
• Intelligent problem fixing before they happen
• Paradigms for efficiency and efficacy of risk control
• World class best practices in risk analysis
• Accounting for risks from unintended use and misuse
• Case histories

Who Will Benefit:

• All Senior Managers
• Software Engineers and Managers
• All Hardware Engineers and Managers
• Software team Leaders
• R&D Staff
• Software Testers
• Quality Assurance Staff
• Regulatory Staff
• Marketing Staff
• Servicing Staff
• Product Safety Staff

Speaker:

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, 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. 

Price: $1,295.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until July 10, Early Bird Price: $1,295.00

From July 11 to August 18, Regular Price: $1,495.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Registration Link – http://bit.ly/1bkF80b