Devices

Risk Documents Key in Device Design: Column

Retired Ethicon senior principal quality engineer Eric Hinrichs says weighing risk versus reward is the key to successful medical device product development. And the way to make such an assessment, he writes in a Med Device Online guest column, is through using risk documents.

“Failure mode and effect analysis documents are designed to work with the medical device’s design team to ensure the new design meets all intended uses and does so in as effective and safe a manner as possible for both the user and the patient,” Hinrichs says. “To effectively accomplish this, it is important to any device’s development to constantly assess changes and modifications of the design against associated risks.”

According to the post, risk documents guide the design team to understand all the myriad ways a device could fail or create a potential harm or hazard, and the best way to minimize or eliminate the identified risks. The documents also provide documented evidence of a device’s risks and how the risks have been reduced or eliminated, as well as what controls or specifications are in place to accomplish this minimization or elimination. “This important documentation is required under design control for the device’s design history file,” Hinrichs writes.

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