According to an article published on the web (Brad Sams at the link provided ), Microsoft has reached the 200 million mark with distribution of Windows 8 licenses. While this is a little behind the pace of distribution for Windows 7 when it was released, it still represents a very large number of sites and is indicative of adoption. Medical device manufacturers of standalone software systems for Windows platform must take notice and prepare for customers moving to this new operating system. As with any configuration change to a medical device, start with risk management and let that that guide the activities and tasks required to qualify a new operating system and/or platform and validate your changed device. If your product required a premarket submission to FDA then you should also consider what type of new submission is needed using a variety of FDA’s guidance documents for submission in general and software submission in particular such as FDA’s Off-The-Shelf (OTS) software guidance.
SoftwareCPR can help you with this process with services as simple as reviewing your plan or as extensive as writing qualification procedures, tests, and new premarket submission for the upgrade to Windows 8. Our experts can provide a helping hand to your staff during crunch times or if your team lacks the experience with regulatory requirements.