Medical Device Engineer (Research & Development)
< 1 min reading time
There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.
Let’s say I am designing a PCB and have to write a protocol to test it. I would include measuring voltages and current at different stages.
But there is much more to consider, even before I plug in the device (like shorts and loose solder connections). Many companies have a team to take care of this, but in a start-up that may not be practical.
My question: What’s a good approach when just starting out in protocol design?
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There are actually two questions here: 1) how to create protocols, and 2) how to test a PCB. In general, protocols are generally for design verification and validation or process validation. There is a GHTF guidance that provides a great template for protocols to do process validation: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
Regarding PCBs…there is a J-standard for inspection, there is inspector certification to that standard, there is certification of trainers for that standard, there is validation of the process (e.g., solder masking and wetting of components with solder), there is automated optical inspection, ICT fixtures, functional test fixtures and x-ray inspection. The design and complexity of the board often determines if some or all of these methods are appropriate.
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