Verification and Validation (V&V) of Software in the Medical Devices

Why Should You Attend:

Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls.

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

Learning Objectives:

Participants will learn

• Why software is too complex to verify?
• The way to validate even complex software.
• The FDA requirements for Verification and validation.

Areas Covered in the Seminar:

• FDA Quality System Requirements for software.
• FDA guidelines on Software Verification and Validation.
• Smart software verification methods.
• How to design smart validation tests.
• How to conduct Black box testing and white box testing to perform thorough validation.
• How to conduct diabolic tests and wicked tests to avoid product recalls.

Who Will Benefit:

• Software developers and managers
• Internal auditors
• Quality Assurance personnel and management
• Software Quality personnel
• Software Test personnel
• Business managers responsible for system compliance
• Regulatory affairs personnel and management
• IT managers and system administrators
• Software Validation engineers
• Regulatory affairs
• Documentation department

Instructor Profile:

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and customer satisfaction.

His focus is on using various types of innovations to encourage a culture conducive to high return on investment. He is the author of the books Assurance Technologies principles and Practices, and Safer Hospital Care. He has served as Associate Professor for the PhD degree in Reliability Engineering at University of Maryland during 1994-99.

Topic Background:

Between 1983 and 1997, 1 in 4 medical devices used software. Today, over 50% devices are run by software. Software governs everything from digital thermometers to pacemakers. The risks can be high and crashes can mean injury or death. A report recommends that the FDA develop procedures to ensure the safety and effectiveness of products before they go to market. This report concludes that many of the software-based devices — including some insulin pumps, infusion pumps that deliver medicine or food to patients intravenously, and defibrillators used in cardiac arrest — are cleared by the FDA through an accelerated process that involves little or no clinical testing. Therefore, companies must find their own way to assure robust validation.

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