CE Mark

Conception

The scientific principles upon which a device is based are fundamental to its safety and performance. The more complex the device, the higher the risk of the user error. Soundness of concept and adequacy of design, construction and testing require the scrutiny of scientific experts to ensure that design parameters and performance characteristics do not impose unwarranted risks.

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Design control

The quality system regulation (21 CFR 820) includes design controls which must be complied with during the design and development of the device. Design control is a systematic way to follow product design from user requirements to final product. Detailed information on design controls can be found in the following FDA guidance documents:

An Introduction to Human Factors in Medical Devices
Design Control Guidance for Medical Device Manufacturers