This SOP describes procedures for controlling and documenting the outputs of the medical device design process so that these outputs can be verified against the design inputs. A matrix form is included to guide the verification process. (6 pages + 1 report form)

$125

This SOP describes methods to verify that medical device product design meets all its detailed design requirements as described in the Design Inputs SOP. Four forms are included with the SOP to guide the process and prepare reports. (12 pages + 4 report forms)

$150

This SOP describes methods to asure that medical device product design meets the product user requirements as explained in the Design Inputs SOP. Five forms are included to guide the process and prepare reports(10 pages + 5 report forms)

$150

This SOP describes a system for orderly formatting, numbering and control of medical device Engineering Drawings. (17 pages)

$125

This SOP provides a standardized format for Engineering Reports and ensures that all necessary information is included. A report template is included. (4 pages + 2 forms)

$125