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Terry Fagen
President at Medipense Inc.
September 2015
Learn from VW: How do you guarantee performance of your medical device software?
< 1 min reading time

We extensively test and use independent verification and validation. What else do you find useful?

source: https://www.linkedin.com/groups/78665/78665-6054306281655721986

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Posted by Terry Fagen
Asked on September 28, 2015 8:00 am
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Karen Boyd, ASQ CQA Risk Management, Internal Verification, Supplier Control
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Joseph Patrissi Ensure proper budget from the beginning to include independent verification.
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Jack Fletcher And let ALL employees know that they are and will be held personally responsible for their actions.... no matter their position.
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Somashekar BV Testing, verification, validation are the later parts of the life cycle. First and foremost is in the design input thinking based on proven technology that has withstood the test of time.
In comparison to the VW and learning from it, we have the similar challenge of power vs size. Batteries for example are challenged to perform with higher mAH capacity as they are made smaller to cater to the ever shrinking overall size of the products or devices. You are getting into an area where there is less and less competency and every company wants to break the size barrier.
Could there be some cheat software to show up false batter status which makes the user more comfortable for extended working ... ?
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VW rigged the SW to operate differently during the test. The SW is designed to run differently under the test conditions than when a customer uses it. This could only happen if lots of people colluded to do something that they should well know is illegal.

I don't think verification testing, risk management, etc. are going to fix this. This is a cultural / management issue.
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Jack Fletcher Jeff, that was my point.
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We set mini goals in the performance of our device, that means lots of unit testing during devolopment, hardware testing, even electromagnetic and material testing. This means that with all the compnent parts performing well,we are assured the whole will also perform well.Its easier and cheaper than testing later.
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Edgar Dieperink, PMP Have the software tested/verified for compliance by a third party partner or an accredited lab.
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Michael B. I missed a bit in this thread, but i will tell you the key to successful verification and validation and verification is what i've always referred to as "inventing the better idiot". I would SAY that this is accomplished through thorough risk assessment, but quite frankly, these days the ones i see are sorely lacking and open to millions in liability suits.

The objective of v&v is testing the limits of a system/device, safeties and equipment to the limits of its service capability to see if it will consistently perform to its expectations.

I know next to nothing about software, but my mechanical designs were always tested to the limits of whatever the worst, hair-brained stunt an idiot could conceive of pulling. It's probably a good golden rule.
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