DESIGN CONTROLS SOP GROUP

DESIGN CONTROLS SOP GROUP

This SOP group contains procedures that will assure that your product development work is conducted in conformance with FDA/ISO requirements including verification and validation.


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This SOP group contains procedures that will assure that your product development work is conducted in conformance with FDA/ ISO requirements including verification and validation.

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$1,650.00
This SOP describes the planning activities necessary for compliant medical device Design Control. Two forms are included in the SOP to guide the process. (12 pages + 2 report forms)
$125.00
This SOP describes the requirements for medical device document and drawing control and changes. Changes recommended by partners or collaborators are controlled.(7 pages)
$125.00
This SOP describes methods to approve and control changes. This procedure is a higher level procedure for the following 2 procedures which coordinates and explains in detail prerelease and post release changes.(5 pages)
$100.00

This SOP describes a method for controlling changes to prerelease documents which is less stringent than the method for post release documents. Post release changes are controlled more closely because these changes involve the manufacturing process, work in process and inventory control.This SOP also controls changes occuring between suppliers and company.(14 pages + 2 forms)

$150.00
This SOP describes procedures for releasing a design and controlling changes post release. It creates classes of change to speed approvals and evaluates effects on work in process and inventory. It considers interactions with vendors and contract manufacturers. (16 pages + 2 report forms: Drawing Release form and Change Request).
$150.00
This SOP describes activities necessary to translate design documentation into medical device manufacturing documentation.(5 pages)
$150.00
This SOP describes methods to review design progress so that the device design process conforms to FDA requirements. Attendees required by the FDA are discussed.An included form leads you through the process. (5 pages + 1 report form)
$125.00
This SOP establishes the content of the medical device Design History File and the requirements for maintaining the DHF. A content checklist is included.(7 pages + 1 report form)
$125.00
This SOP describes methods for the establishment, approval and documenting of requirements for a new medical device product. Two forms are included in the SOP: User Requirements and Product Requirements (7 pages + 2 report forms)
$125.00
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)
$125.00
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)
$150.00
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)
$150.00
This SOP describes a system for orderly formatting, numbering and control of medical device Engineering Drawings. (17 pages)
$125.00
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)
$100.00