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.
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.
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.
Subscribe to the blog and get this guide for free