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design controls | Product Development | SWOT | Cape Cod | SCRUM | Agile | Engineers | Developer

Multi-Day, Core Development Team Off-Site

By: Michael J Lowe II
February 23rd, 2017

Cognition held two strategic off-site multi-day meetings in a stunning area of Cape Cod with members of the core development and application engineering leadership teams. Whenever Cognition holds these events, we use the time to get our leadership groups to talk about what the company can do to improve business and employee satisfaction.

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design controls

3 Difficulties in Design Controls

By: Michael J Lowe II
January 18th, 2017

1. Human Factors Human error, presumably, is the most common cause for failure. Either the user failed to implement a device correctly, or the company producing the product failed to predict improper use. The goal for companies is to minimize those failures. In order to do that, they must think through the many ways devices can fail through human error and strive to design around them to produce the safest device possible.

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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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design controls

21 CFR 820.30 for Dummies (i.e. Me)

By: Michael J Lowe II
May 25th, 2016

21 CFR 820.30 is the bread and butter of the medical device world. It governs over all Class II and III devices and a handful of Class I devices. FDA classifies devices based on the associated risk. There are three categories: Class I, Class II and Class III. Dental floss is Class I because it is low risk. A condom is Class II because there needs to be reasonable assurance of its safety and effectiveness. Class III are the highest risk devices, such as a replacement heart valve.

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