Design Controls, Deconstructed

Industry terminology in the medical device field is so robust it could be declared an official language. And just as languages develop dialects that alter the meaning of a word or phrase depending on where it is spoken, the same is true in the medical device industry. One common debate is the precise definition of the term “design controls.” The varied interpretations of that label create ambiguity.   Design Controls Design controls are the means a medical device developer uses to prove that a product is safe, it works, and it is suited to the needs of the market. This post breaks down what design controls encompass, what they entail, and how your entire medical device initiative benefits from well-planned design controls. Design Controls Background: FDA 21 CFR Part 820 vs. ISO 13485:2016 Design controls fall under FDA 21 CFR Part 820, Quality Management System Regulations. The term “design controls” originates from FDA. As it is the law in the United States, adhering to design controls requirements is required. ISO 13485:2016 is, as you know, a voluntary standard. That said, since ISO standards are written with input from worldwide medical device regulators, ISO 13485 compliance is an acceptable approach that satisfies regulatory auditors. ISO 13485:2016 content related to FDA’s 21 CFR Part 820 is found in ISO 13485 Section 7.3, “Des...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news