Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Validating your system for FDA and ISO
Both FDA and ISO13485 require that any software you use for quality must be validated for use, whether a spreadsheet, testing software and even your QMS software. Whether you purchased “off-the-shelf” (OTS) or created it yourself, it should be validated to perform as intended in their chosen regulatory application.
For this you have to have the right validation strategy and content. Without specific parameters or with the wrong requirements, you might end up approving things that might turn out to be quite different from what you expected.