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elctrnx_lyf
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Good News
elctrnx_lyf   3/25/2014 8:57:48 AM
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This is a definitely a good news and underlines the importance of regulations applied in the medical device industry.

docdivakar
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Re: Medical Device Recalls Growing...
docdivakar   3/25/2014 6:40:31 PM
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Thanks for this informative article. What is surprising to me that software is listed as one of the major causes for recall. Could it be that the major reason for this is that the product vendors like to keep control of updates to firmware/software?

MP Divakar

Sanjib.A
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Re: Medical Device Recalls Growing...
Sanjib.A   3/26/2014 2:14:59 PM
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The FDA report says:

"The most frequent causes for recalls are related to device design, software, and non-conforming material or component issues."

All of these failures such as inappropriate design, software bug & non-conforming material or component use sound like "systematic failures" to me, which could be avoided (ideally) by rugged processes, reviews, testing and also by adhering to the best practices & processes, procedures as recommended in the standards.



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