I would also follow the ISO requirements and guidelines regardless of enforcement. I feel that developing a medical device that causes users harm during testing and execution defeats the purpose of developing the device in the first place. Users put their trust into the claims made by the medical device companies and it is their responsibility to uphold it. Even if we disregard morality, there will be a rise in lawsuits and compensation that the company will have to pay for in the event of causing damaging side effects. Eventually, the company will have to file for bankruptcy, which will put a stop to future projects and opportunities for success. The risk of harming users coupled with the company going under, overrides the cuts in cost and time from taking illegal shortcuts.