Which subpart of 21 CFR Part 820 explains about design control?

21 CFR Part 820 Subpart C—Design controls What it covers: 21 CFR Part 820 Subpart C covers design controls. Design controls are procedures that ensure devices are designed according to their requirements.

What are design input requirements?

Design inputs are the physical and performance characteristics of a device that are used as a basis for device design. Establish and maintain procedures for Design Input: – Ensure requirements are appropriate by addressing user needs and intended use(s) in terms that are measurable.

How do you verify a design?

Design Verification Process

During the development stage of a specification, the identification of verification activity is done parallel.
Identifying the best approach to conduct verification, define measurement methods, required resources, tools, and facilities.

What is the difference between design input and design input requirements?

From the FDA design control guidance: “Design input is the starting point for product design. The requirements which form the design input establish a basis for performing subsequent design tasks and validating the design.

What is FDA 21 CFR Part 820?

FDA 21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

What is 21 CFR Part 820?

In short, FDA 21 CFR Part 820, also known as the Quality System Regulation QSR which outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished medical devices intended for

What is 21 CFR Part 11?

21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures.