Med Device Advisors Sells Medical Device SOP's
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Categories SOPs_Available DESIGN CONTROLS SOP GROUP
DESIGN CONTROLS SOP GROUP
This SOP group contains procedures that will assure that your medical device product development work is conducted in conformance with FDA/ISO requirements including verification and validation.
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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 |
$125.00
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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 |
$150.00
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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 |
$150.00
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This SOP describes a system for orderly formatting, numbering and control of medical device Engineering Drawings. (17 pages) $125 |
$125.00
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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 |
$125.00
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