Question

The QSR for medical devices regarding Design Controls require which of the following:

A) Documentation of early research of the design
B) Design and development plans address how design inputs and requirements are managed
C) A product design can be outsourced by a manufacturer so they do not have to maintain the documentation
D) Design activities are only required for Class III Investigational devices

Answer 1

The QSR for medical devices requires design and development plans to address how design inputs and requirements are managed.

Step-by-step explanation:

The QSR (Quality System Regulation) for medical devices regarding Design Controls require the following:

A) Documentation of early research of the design

B) Design and development plans address how design inputs and requirements are managed

C) A product design cannot be outsourced by a manufacturer so they must maintain the documentation

D) Design activities are required for all classes of medical devices, not just Class III Investigational devices

Therefore, the correct answer is B) Design and development plans address how design inputs and requirements are managed.