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  • Maybe I worded the original post poorly. Yes, violating the current standards can be dangerous to the end user & costly to the company.

    As more regulations are developed, making medical devices become more cumbersome. Because of this, medical device companies may neglect a certain area of research due to the heavy financial or time burden. Or (and this may be the case with Philips) they cut corners in places that they feel are redundant in hopes of not being caught. So in that case, they would alter the regulation (if they could) to avoid the redundancy.

    Let’s look at a separate company, Thanos Inc. This company is working on Power Glove Deluxe and the head of the company is adamant that everyone quadruple check each step in the development process. This just so happens to align with the regulation that Philips does not like due to them feeling it is redundant.

    Say Philips was able to change the regulation that they felt caused redundancy, Thanos, Inc would still quadruple check each step anyway because to them it’s the right thing to do.

    What I am asking is if there is a standard that, although it could be perceived as not needed to another company, you would make sure your company follows if it was decided today that it was no longer needed? If so, what standard is it?