The Life and Death Testing of Medical Devices | TechWell

The Life and Death Testing of Medical Devices

Are you a superhero? Do you save lives every day? If one software profession can claim that, it is the job of the software tester for medical devices.

It is a huge responsibility to ensure thorough testing of the devices people rely on for their lives and health. This presentation on medical device testing highlights the challenges involved.

The presentation on Ensuring Software Quality in Life-Saving Medical devices by Florian Mösch shows his company’s approach to quality. The talk highlights some of the terrible failures or lack of testing in some of the devices that have been releasedwith some awful consequences.

Medical device testing is really about embedded testing. It requires a different and more rigorous approach to testing than your normal web application. 

Regulation standards that were supposed to be raised back in 2007 haven't prevented some serious failures since then. Regulation still needs to be addressed. Some companies believe that software testing requires morein addition to code coverage which is a vital part of medical device testing.

Medical device testing really needs every tool available to quality analysts and software developers thrown at itrequirements traceability, test-driven development, code reviews, regression automation, code coverage, test case reviews, and maybe even dual test teams where two testers are given the responsibility to test the same software. 

The cost of failure in medical devices is high as this example shows. Companies must ensure they do everything possible to find bugs in a system. That means ensuring their budgets and schedules have enough money and time for testing plus independent external testing audits of their systems.

Medical device testers should be highly qualified, be trained in the product, get experience in real life application of the product, have knowledge of product history, and be well read in the area of medical device quality.

It would be interesting to know the test methodologies medical device companies employ in their product development. Is there a standard out there like CMMI Level 5, FDA regulation standards—or even better?

How rigorous are your quality controls? Do you test from product inception or just at the end? Let us know.

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January 9, 2013

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