I stumbled across this PowerPoint presentation the other day. John Murray at the FDA put together this presentation that spells out expectations regarding patching off the shelf (OTS) software used in medical devices. If you want to know the real story, check it out. The term guidance is in quotes because this is an informal communications, rather than a formal guidance document.
About The Author
After almost 25 years in health care Tim remains with his first love, connectology, the automation of workflow through the integration of medical devices with information systems.
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