Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Back in February 2018, Capt. Sean Boyd, the deputy director of regulatory affairs with CDRH’s Office of Compliance, gave a talk at Xavier Health’s Half Day with the FDA web conference. In the talk, he laid out steps FDA is now taking to transform CDRH through the Total Product Lifecycle (TPLC) realignment initiative.
We’ve been up to a lot here at Cognition since the start of the new year—too much, in fact, to cover in a single blog. However, we’d love to catch you up with some of our favorite highlights from the past few months!
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The FDA Pulse Check is a monthly series of blog posts from Cognition focusing on the latest news, updates, and information from FDA relating to life sciences industries. Spring is here, and FDA has been up to some interesting stuff. Take a look at some of the latest FDA updates we found interesting and worthwhile!
In the “Classify Your Medical Device” blog series, we look at each classification and what is required for your device to move from development to commercialization. Want to start at the beginning of the series? Click here! We’ve now seen how FDA’s medical device classification system distinguishes between Class I and Class II devices. As well, we’ve established how intended use, indications for use, and risk management are the biggest influencers for a device’s classification. Now let’s look at Class III and what it means for your device.
What’s the best way to take care of a family as big as ours? Simple: a home-cooked meal and some social time.
Have you started up a new, innovative life sciences company? Are you thinking about relocating your existing business, or want to expand your reach across the US with additional facilities? Whatever the case, you’ll want to make sure you’re located where your business can thrive. But what cities will provide you opportunities to do so? We took a look at four great cities (in no particular order) with flourishing life science sectors for you to consider.
Early-stage innovation for life science products involves a lot of high-level thinking. But before you even begin identifying ideas and solutions for your customers, you should develop a holistic view of their needs. Doing this helps you see what areas of their experience are underserved or could possibly benefit from some form of innovation.
Please join Cognition and Minneapolis locals at the 2018 Healthcare Systems Engineering Conference.
Have you heard this term before? While it seems like a nebulous part of the innovation process, it actually has some structure, and can be done around design stages and activities that help teams flesh out product concepts and begin to innovate.