Medical Device Software Recalls on the Rise What’s Causing Them, What the FDA is Doing About Them, and What Manufacturers Should Do to Prevent Them

$527.00
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1 - 9999
$527.00
1 - 9999
$327.00
1 - 9999
$527.00
1 - 9999
$327.00
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.

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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 encore presentation will not be a recitation of regulations; it will be 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 encore presentation, join device software expert Dr. David Vogel as he dissects these reports from a technical perspective to provide some understanding of what is behind this alarming 25% statistic.

Attendees will gain an in-depth understanding of:

  • Typical causes of software failures that lead to device recalls
  • What the FDA is doing to reduce medical device software failure rates
  • What manufacturers can do to improve their own software success rates
  • What materials, training and tools are available to build better software

You and your colleagues will participate 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, interactive learning via the Web.

Device software is a tough and demanding business with little room for error.  Don’t risk being the FDA’s next recall. Sign up today for Medical Device Software Recalls on the Rise.

Register now.

This encore presentation 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.

  • Software engineers
  • Regulatory compliance officers
  • Quality assurance directors
  • Senior management
  • Manufacturing managers

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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Date: Oct. 1–19, 2012
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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