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Medical Software ValidationChallenges in 2014

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• Formerly QA Manager of LoadRunner at Mercury Interactive• M.Sc. cum laude in Bio-Medical Engineering• M.Sc. in Mechanical Engineering

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• Risks• Costs

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• Trends• Challenge

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1. Coding finished2. Run a few tests3. System approved4. Release

Result: Disaster ! Inadequate design or poor

coding produces many time bombs in the system!

← High Risk Approach

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Therac-25 medical accelerator (1985-1987)

• Therac-25 was a therapy system that delivered two different kinds of radiation: either a low-power electron beam or X-rays.

• The Therac-25's X-rays were generated by smashing high-power electrons into a metal target positioned between the electron gun and the patient.

• An electromechanical safety interlock was replaced by a software control, because software was perceived to be more reliable.

• The OS was compiled by a programmer with no formal training. • Because of a “race condition” bug, the operator could accidentally configure the

Therac-25 so the electron beam would fire in high-power mode, but with the metal X-ray target out of position.

• At least five patients died; others were seriously injured.

Catastrophic software failure

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QC → ProductsQA → Processes

ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

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← Low Risk Approach1.SW Lifecycle2.Documentation3.Risk Analysis4.Specifications (functional, performance, usability, etc.)

5.Requirements (marketing, technical, user expectations, etc.)

6.Code Review (manual, automatic)

7.Code Freeze8.Version Management9.Bug Base10.Validation & Verification

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• Risks• Costs

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• Trends• Challenge

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What are mobile medical apps?Mobile apps are software programs that run on smartphones and other mobile communication devices.

How will the FDA regulate mobile medical apps?The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.

Last Updated: 10/22/2013 

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Does the FDA regulate mobile devices and mobile app stores?

FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.

Last Updated: 10/22/2013 

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When is a mobile app classed as a medical device?

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• Currently available for iOS devices. • Helps doctors calculate the percentage of

a patient’s body surface area that is burned.

• Calculates the amount of fluid to be administered in the 24-hour period that follows the burn injury.

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THE DARIO PLATFORM

DarioTM is a state-of-the-art in diabetes management platform that connects the user, caregiver and healthcare professional anywhere in the world. Dario‘s cloud-based software provides you with an easy seamless way to record, save, track, analyze, manage & share all your diabetes related information in one lifestyle management platform.

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Meeting the Challenge:

1. Methods (V-model, Risk Manage)

2. Tools (Functional, Performance)

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Automated iPhone Testing using Open Source Tools:

This is a demonstration of how to automate the iOS platform / iPhone automation using Open Source tools; compatible with ANT and Maven in any continuous environment.

In this demo we show you how Open Source can perform a basic test in an iPhone app and run through both positive and negative testing.

Uploaded on Apr 7, 2011

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http://www.ibm.com

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