Designing for Compliance: QMS & Validation Testing for SaMD vs. Physical Devices

“God is in the details” is an old German proverb that Nietzsche (not surprisingly) paraphrased to the more common saying “the Devil is in the details.” While Nietzsche knew nothing about medical device regulatory compliance and testing, anyone experiencing the journey to FDA approval would agree that the process often feels more devilish than divine. [&