Medical Device Product Development

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.

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Thought Leadership | Industry Updates

CDRH Reorganization: How Will It Impact Your Medical Device Organization?

By: Nick Schofield
April 19th, 2018

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.

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Cognition News

What's New with Cognition?

By: Alex Critch
April 18th, 2018

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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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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Thought Leadership | Industry Updates

FDA Pulse Check: March 2018

By: Nick Schofield
April 10th, 2018

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!

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Thought Leadership

Classify Your Medical Device: Class III

By: Nick Schofield
April 5th, 2018

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.

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Cognition News

Taking Care of the Cognition Crew

By: Alex Critch
April 3rd, 2018

What’s the best way to take care of a family as big as ours? Simple: a home-cooked meal and some social time.

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Thought Leadership

4 US Cities with Thriving Life Science Sectors

By: Nick Schofield
March 28th, 2018

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.

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Thought Leadership

3 Tips for Journey Mapping in Life Sciences Innovation

By: Nick Schofield
March 22nd, 2018

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.

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Cognition News

You're Invited to the INCOSE Healthcare Working Group 4th Annual Systems Engineering in Healthcare Conference!

By: Alex Critch
March 20th, 2018

Please join Cognition and Minneapolis locals at the 2018 Healthcare Systems Engineering Conference. 

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Thought Leadership

What in the World is the "Fuzzy Front End" of Innovation?

By: Nick Schofield
March 15th, 2018

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.

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