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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$1850

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)

$150

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

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)

$150

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)

$175

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).

$200

This SOP describes activities necessary to translate design documentation into medical device manufacturing documentation.(5 pages)

$150

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

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

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)

$175