Device, software, recalls. Device, software, recalls. These 3 words keep popping up in the halls of FDA.
A recent FDA report found 25% of all recalled devices were the result of bad software. If your product has embedded software — or is connected via a network — you now have a 1 in 4 chance of being recalled.
More and more medical devices used for critical care are reliant on software. And they’re increasingly connected to networks. But little has been done to understand the malware and security vulnerabilities they face.
Poor programming or deficient software updates are impacting the safety and effectiveness of computer-controlled medical devices — and the FDA is taking action.
Unlike computers, life sustaining medical devices must keep working even in the face of errors or attacks. You cannot simply close the device down and restart.
This audio CD/Transcript is not a recitation of regulations; it is a study of what is failing in the software industry, why those failures are not detected during product development, and what can be done to improve the situation.
In this 90-minute audio CD/Transcript, device software expert Dr. David Vogel dissects these reports from a technical perspective to provide some understanding of what is behind this alarming 25% statistic.
Listeners will gain an in-depth understanding of:
You and your colleagues can listen from the comfort of your own office, conference room or auditorium. No planes, no hotels, no precious time away from work and family — just 90 minutes of solid learning.
Device software is a tough and demanding business with little room for error. Don’t risk being the FDA’s next recall.
This audio CD/Transcript is intended for software engineering, quality and regulatory compliance professionals who are responsible for risk management, hazard analysis, and/or validation of software that is embedded in a regulated medical device, connected via a network or is itself considered a medical device.
Dr. David Vogel founded Intertech Engineering Associates in 1982 and since then has served the medical device industry by providing electronics hardware and software development services. He and his engineering team have developed engineering processes for Intertech that facilitate product design compliance with FDA Quality System Regulations. As an author (Medical Device Software: Verification, Validation, and Compliance, 2010), a frequent speaker at trade events and an AAMI instructor, Dr. Vogel has trained thousands of attendees publicly and privately on topics related to product development, validation, design controls, risk management and the development of corporate policies and procedures for device development.
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