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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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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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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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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