Risk control and usability white paper

Bedford, Massachusetts – The FDA requires medical device manufacturers to follow a strict set of guidelines in order to ensure compliance and safety for all devices going to market. These regulations and guidelines are confusing to understand which often leads to the FDA issuing Form 483s and Warning Letters to manufacturers out of regulation. This new series will aid in understanding the failures so many face as well as ways to avoid and overcome them.

The first paper in the Cognition series was just released; the topic being “Risk Management and Usability are Key Factors in the Success of Product Design, Making Them a Focus Point in the Design Controls Discussion: A Systematic Review of 483 Data and Common Breakdowns in 21 CFR 82.30”. The paper does a systematic review of Form 483s and Warning Letters issued by FDA and other common breakdowns in 21 CFR 820.30. The white paper reviews Risk Management and Usability as important topics within design control, which can aid manufacturers in developing a more successful product.

Download the free white paper here.

Source: Cognition Corp.