150$150.00 Form that provides classification criteria for the change as well as a decision tree for determination of substantial and nonsubstantial changes. 150 quantity + SKU: IFRM029 Category: Form Related products Template, Manufacturing Assessment-MDR – $150 $150.00 + PMSP Template-MDR – $150 $150.00 + Phase Review Form – $150 $150.00 + PMSP Template-IVDR – $150 $150.00 +