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Author: <span class="vcard">admin</span>

Draft for a second corrigendum for the MDR published

December 3, 2019 admin Leave a comment

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Home Healthcare Medical Devices

November 2, 2017 admin Leave a comment

Designing devices for home healthcare? Some key areas to consider… The collateral safety standard that applies to active medical devices is…

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Insider tips to speed-up your product certification

September 10, 2017 admin Leave a comment

In general, there are 3 stages to certify a product; construction review, testing and technical report. Guess where most of…

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Does your PCB/PWB meet the requirements?

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There are several requirements that you have to meet when designing your medical device that incorporates printed circuit/wiring boards (PCBs/PWBs).…

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Why are the leakage current limits for patient and operator different?

September 8, 2017 admin Leave a comment

This may seem obvious for most, but some forget the importance of understanding the “intent” of the requirements. For some,…

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Insider tips to speed-up your product certification

admin Leave a comment

In general, there are 3 stages to certify a product; construction review, testing and technical report. Guess where most of…

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What are the key requirements for “critical components”​?

admin Leave a comment

In an earlier post, I answered and provided basic examples to the question, What are “critical components”? But, before moving-on…

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What are Critical Components?

admin Leave a comment

The absence or failure of a component (electrical or non-electrical) that can result in “unacceptable risk”. Electrically speaking, these are…

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