Avoid dissater
Gebäudereinigung Marburg you have any software in your device, and these days who doesn't, a Traceability Matrix (TM) is one of your best friends. Traceability is required by regulations. For FDA, 510(k), DeNovo or PMA, a traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how it is all connected, where and how requirements were met. For the CE mark, the requirements are similar, if not the same! Failure to provide full traceability of documentation is one of the FDA's top 5 violations. A non-compliant FDA or CE audit is costly, no matter who you are... small or big, but especially if you're a startup. "Failure to adequately document design input requirements as required by 21 CFR 820.30(c)... your firm did not define and document clear, appropriate design input requirements... " Another costly mistake is to assume that an FDA inspector will review only the recent design history files and not the whole