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 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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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

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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Thought Leadership | Industry Updates

FDA's Class II Special Controls Designations Are On The Rise; How Will Your Device Be Affected?

By: Larry Nicholson
December 6th, 2017

Over one-third of all Class II devices now have “Special Controls” designations from FDA. The rate of such classifications in the last seven years has increased by over 240 percent (Desjardins 2010). What is driving this trend?

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Thought Leadership

Human Factors and Your Supply Chain

By: Nick Schofield
November 28th, 2017

Why should you care about completing human factors engineering (HFE) in relation to your supply chain? Simple: humans are involved. At every stage of your medical device’s lifecycle, there are people participating in assembly, handling, packing, and so on. Particularly during manufacturing, your team wants to focus on HFE exercises to help control risks that could arise in later lifecycle stages. But what manufacturing steps should be evaluated with human factors in mind?

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Thought Leadership | Industry Updates

FDA Pulse Check: October 2017

By: Nick Schofield
October 12th, 2017

As the year begins to wrap up, FDA is finalizing several pieces of guidance and initiatives as it heads into FY 2018. Here are some previews and highlights for October: National Cybersecurity Month.

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