3hr Virtual Seminar on Designing Medical Device Software to Prevent Product Recalls

Why Should You Attend:

Many medical devices are controlled by software that governs key aspects of the user interface, and performs key safety functions. Users often do not realize the extent to which software determines many of the key functional and performance characteristics of the system until something goes wrong. Unfortunately, in some cases, the software does “go wrong” and compromises performance reliability and patient safety. Because software is inevitably complex, abstract, and intangible, design errors can be difficult to detect. The occurrence of a software error should be a highly unusual event.

The trend of recalls of products containing software is up. Historically, software safety has been focused on the software development process and system-level testing.. Having skilled engineers and a rigorous software development process, as required by the FDA is important to help to minimize errors. However, assessing the software development process provides only a partial reliability of the software, and system-level testing that would comprehensively test the software is currently beyond the state of the art except for a very simple system. How we design the software reliability and safety is critical in preventing recalls.

Attend this training to learn proven techniques for designing reliable and safe medical device software that can prevent product recalls.

Areas Covered in the Seminar:

• FDA Quality System Requirements.
• Principles of software reliability.
• Principles of software safety.
• Software requirements analysis methods.
• Software Failure Mode and Effects Analysis.
• Software Hazard Analysis.
• Software structure for reliability and safety.
• Software architecture for reliability and safety.
• Manual code reviews.
• Software verification.
• Software validation.
• Exhaustive system testing.
• Risk analysis.

Who Will Benefit:

This webinar will provide valuable assistance to all Medical Device companies/ manufacturing sites. Those that would benefit most would be:

• Software R&D
• Software Engineers, System Engineers
• Software Project Managers
• Hardware Development
• Product Management, Product development
• Safety
• Regulatory
• Purchasing & Production
• Quality Assurance Managers
• Suppliers and Software Vendors

Personnel in the hospital and healthcare industry would also benefit from this training.

Instructor Profile:

A respected and sought out expert on medical device and hospital care safety, author Dev Raheja 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 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 patient 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.

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