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

Classify Your Medical Device: Class II

By: Nick Schofield
February 21st, 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. By now, you’re familiar with the basics of FDA’s medical device classification system. The system’s classes (Class I, Class II, Class III) all relate to how much risk is posed to patients and/or users, along with device effectiveness and reliability plus the intended use. So, what is the threshold of these factors that make a device Class II instead of Class I?

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Thought Leadership

3 Myths of Life Science Innovation You Still Believe

By: Nick Schofield
February 8th, 2018

So-called “innovation insights” are a dime a dozen in life science industries today. How can you distinguish which are fact versus myth?

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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: January 2018

By: Nick Schofield
January 25th, 2018

Welcome to the new regulatory year! Here are some FDA updates worth following this month:

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Thought Leadership

Classify Your Medical Device: Class 1

By: Nick Schofield
January 18th, 2018

How are medical devices classified by FDA? What does classification mean for your product?

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Thought Leadership | Industry Updates

Why is Apple’s New Medical Device Accessory So Important?

By: Nick Schofield
January 11th, 2018

With FDA’s clearance of AliveCor’s KardiaBand EKG reader, the Apple Watch now has its first medical device accessory. This is a big deal in the medical device industry, but why?

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Thought Leadership

Will FDA Require These 3 Controls for Your Device Compliance?

By: Nick Schofield
January 4th, 2018

Do you know if your medical device is classified as Class II Special Controls? Does your submission provide “reasonable assurance(s) of safety” to FDA? Knowing the answers to these questions ahead of time saves you time, energy, and hassle. If you’re unsure, search FDA’s device classification page for your device type; if it’s classified as Class II Special Controls, you may need to satisfy these three controls:

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Cognition News

We Went to FDA SOP Training!

By: Nick Schofield
December 21st, 2017

Earlier this month, we sent two members of our Cockpit Crew down to Virginia for training on Standard Operating Procedures. As part of Cognition’s ongoing effort to educate ourselves and expand the scope of our product offerings, we decided it would be worthwhile to get more training in technical writing.

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Thought Leadership | Industry Updates

FDA Pulse Check: Novemeber/December 2017

By: Nick Schofield
December 19th, 2017

Our Thought Leadership series, “FDA Pulse Check,” attempts to highlight and break down the latest news, updates, and initiatives from FDA relevant to medical device, pharmaceutical, and combination product industries.

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Cognition News

Cognition Corporation Announces Appointment of New CTO

By: Alex Critch
December 14th, 2017

We are excited to announce the appointment of David Taylor to the CTO position at Cognition Corporation. Mr. Taylor has been with Cognition for over 19 years. During that time, he has held positions as Cockpit Development Lead, Lead Cockpit Architect, and most recently, Vice President of Software Development.

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