It’s Not Just About Meeting FDA Requirements

Wednesday, October 28, 2015

Source: MDT

Manufacturers of medical devices are rightly required to demonstrate how human factors considerations are taken into consideration during a product’s development. The aim of the FDA’s requirements is quite simple - that manufacturers make a systematic assessment of who will be using a device, the conditions under which it will be used, how it will be used and whether it can be used safely. FDA 510(k) Human Factors Guidance is a key consideration for all companies in the medical device sector.

The result of understanding the people who actually use the devices – healthcare professionals, patients, and caregivers – is that they have become safer and much less prone to user error. However, as with all regulations, the rules are often seen as a cost in product development, and the temptation is for the minimum to be done to reach the required standard – to keep costs down.

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