View all productsA-F Aging, Conditioning and Transport-IVDR – $250 $250.00 + Aging, Conditioning and Transport-MDR – $250 $250.00 + Basic UDI-DI procedure-IVDR – $250 $250.00 + Basic UDI-DI procedure-MDR – $250 $250.00 + Business Profile – $150 $150.00 + CAPA Escalation Procedure-IVDR – $250 $250.00 + CAPA Escalation Procedure-MDR – $250 $250.00 + CAPA procedure-MDR – $250 $250.00 + Closed Loop PMS “CPLS” Roadmap-IVDR – $500 $500.00 + Closed Loop PMS “CPLS” Roadmap-MDR – $50 $50.00 + Complaint Handling, Distributor – $250 $250.00 + Complaint Handling, Importer – $250 $250.00 + Complaint Trend Analysis Template-IVDR – $150 $150.00 + Complaint Trend Analysis Template-MDR – $150 $150.00 + Corrective Action and Preventative Action Procedure-IVDR – $250 $250.00 + Corrective Action and Preventative Action Procedure-MDR – $250 $250.00 + Customer Feedback Procedure-IVDR – $250 $250.00 + Customer Feedback Procedure-MDR – $250 $250.00 + Data Analysis Procedure-IVDR – $250 $250.00 + Data Analysis Procedure-MDR – $250 $250.00 + Data Analysis-IVDR – $250 $250.00 + Data Analysis-MDR – $250 $250.00 + Design Controls-IVDR – $250 $250.00 + Design Controls-MDR – $250 $250.00 + Design Development Plan-MDR – $150 $150.00 + Device Master Record Template – $150 $150.00 + Device Master Record Template-MDR – $150 $150.00 + Distributor Supply and Quality Agreement-MDR – $150 $150.00 + Document Control-IVDR – $250 $250.00 + Document Control-MDR – $250 $250.00 + Economic Operator Procedure, Distributor – $250 $250.00 + Economic Operator Procedure, EU Manufacturer – $250 $250.00 + Economic Operator Procedure, Importer – $250 $250.00 + Economic Operator Procedure, Non-EU Manufacturer – $250 $250.00 + Equipment Qualification Procedure-IVDR – $250 $250.00 + Equipment Qualification Procedure-MDR – $250 $250.00 + Field Safety Notice/Field Safety Corrective Action Procedure-IVDR – $250 $250.00 + Field Safety Notice/Field Safety Corrective Action Procedure-MDR – $250 $250.00 + Form, Health Hazard Analysis-IVDR – $150 $150.00 + Form, Health Hazard Analysis-MDR – $150 $150.00 + Form, Vigilance Assessment-IVDR – $150 $150.00 + Form, Vigilance Assessment-MDR – $150 $150.00 + FSCA/FSN/Recall, Distributor – $250 $250.00 + FSCA/FSN/Recall, Importer – $250 $250.00 + G-K Health Hazard Analysis Procedure-IVDR – $250 $250.00 + Health Hazard Analysis Procedure-MDR – $250 $250.00 + Identification Handling/Storage – $250 $250.00 + Implementing Transition Requirements, Quality Plan-IVDR – $500 $500.00 + Implementing Transition Requirements, Quality Plan-MDR – $500 $500.00 + Initial Registration, EUDAMED for EU Importers – $250 $250.00 + Initial Registration, EUDAMED for EU Manufacturers – $250 $250.00 + Initial Registration, EUDAMED for NON-EU Manufacturers – $250 $250.00 + Job Descriptions/Competency with PRRC and EUDAMED roles define-IVDR – $150 $150.00 + Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR – $150 $150.00 + L-P IVDD to IVDR QMS Transition, Quality Plan-IVDR – $500 $500.00 + Marketing Specification – $150 $150.00 + Marketing Specification-MDR – $150 $150.00 + Material of Concern Evaluation Process-IVDR – $250 $250.00 + Material of Concern Evaluation Process-MDR – $250 $250.00 + Materials of Concern (MoC) Editable List-IVDR – $150 $150.00 + Materials of Concern (MoC) List-MDR – $150 $150.00 + MDD to MDR QMS Transition, Quality Plan-MDR – $500 $500.00 + MDR Transition Plan-MDR – $500 $500.00 + Measurement System Analysis-IVDR – $250 $250.00 + Measurement System Analysis-MDR – $250 $250.00 + Normative/Standards Watch-IVDR – $250 $250.00 + Normative/Standards Watch-MDR – $250 $250.00 + Packaging Validation Plan-IVDR – $250 $250.00 + Packaging Validation Plan-MDR – $250 $250.00 + Phase Review Form – $150 $150.00 + Phase Review Form-MDR – $150 $150.00 + PMSP Procedure-IVDR – $250 $250.00 + PMSP Procedure-MDR – $250 $250.00 + PMSP Template-IVDR – $150 $150.00 + PMSP Template-MDR – $150 $150.00 + Post Market Surveillance Procedure-IVDR – $250 $250.00 + Post Market Surveillance Procedure-MDR – $250 $250.00 + Preventative Maintenance-IVDR – $250 $250.00 + Preventative Maintenance-MDR – $250 $250.00 + Process Validation Procedure-IVDR – $250 $250.00 + Process Validation Procedure-MDR – $250 $250.00 + Production Software Validation-IVDR – $250 $250.00 + Production Software Validation-MDR – $250 $250.00 + PSUR Procedure-MDR – $250 $250.00 + PSUR Procedure-MDR – $250 $250.00 + PSUR Template-IVDR – $150 $150.00 + PSUR Template-MDR – $150 $150.00 + Transition Quality Plan-IVDR – $500 $500.00 + Q-T QMS Transition Roadmap-IVDR – $500 $500.00 + QMS Transition Roadmap-MDR – $50 $50.00 + Quality Planning Procedure-IVDR – $250 $250.00 + Quality Planning Procedure-MDR – $250 $250.00 + Receiving Inspection Form, Distributors – $150 $150.00 + Receiving Inspection Form, Importers – $150 $150.00 + Record Control for Distributor/Importers – $250 $250.00 + Regulatory Plan – $150 $150.00 + Regulatory Plan-MDR – $150 $150.00 + Regulatory Watch-IVDR – $250 $250.00 + Regulatory Watch-MDR – $250 $250.00 + Risk Management Plan, Distributor – $250 $250.00 + Risk Management Plan, Importer – $250 $250.00 + Risk Management Policy – $150 $150.00 + Risk Management procedure-IVDR – $250 $250.00 + Risk Management procedure-MDR – $250 $250.00 + Risk Management Procedure, Distributor – $250 $250.00 + Risk Management Procedure, Importer – $250 $250.00 + Risk Management Remediation Quality Plan – $500 $500.00 + Risk Management Remediation Roadmap-IVDR – $500 $500.00 + Risk Management Remediation Roadmap-MDR – $50 $50.00 + Risk Management Transition, Quality Plan-IVDR – $500 $500.00 + Risk Management Work Instructions – $250 $250.00 + Risk Management Work Instructions-MDR – $250 $250.00 + Risk Management Workbook – $150 $150.00 + Risk Management Workbook-MDR – $150 $150.00 + Risk Management Workbook, Distributor – $150 $150.00 + Root Cause Analysis Procedure-IVDR – $250 $250.00 + Root Cause Analysis Procedure-MDR – $250 $250.00 + Software Assessment Form-IVDR – $150 $150.00 + Software Assessment Form-MDR – $150 $150.00 + Software Validation, Risk Management Workbook – $1000 $1,000.00 + SSCP Procedure-MDR – $250 $250.00 + SSCP Template-MDR – $150 $150.00 + Statistical Techniques Procedure-IVDR – $250 $250.00 + Statistical Techniques Procedure-MDR – $250 $250.00 + Template, Benefit Risk Assessment Template-IVDR – $150 $150.00 + Template, Benefit Risk Assessment Template-MDR – $150 $150.00 + Template, Manufacturing Assessment-IVDR – $150 $150.00 + Template, Manufacturing Assessment-MDR – $150 $150.00 + Template, Master Validation Plan-MDR – $150 $150.00 + Template, Product Materials Assessment-MDR – $150 $150.00 + Template, Quality Monitoring Plan-MDR – $150 $150.00 + Template, Risk Management Plan – $150 $150.00 + Template, Risk Management Plan-MDR – $150 $150.00 + Template, Risk Management Report-IVDR – $150 $150.00 + Template, Risk Management Report-MDR – $150 $150.00 + Training, Distributors and Importer Responsibilities – $300 $300.00 + Trend Analysis Report Template-IVDR – $150 $150.00 + Trend Analysis Report Template-MDR – $150 $150.00 + U-Z UDI Implementation Plan Template-IVDR – $150 $150.00 + UDI Implementation Plan Template-MDR – $150 $150.00 + UDI-DI procedure-IVDR – $250 $250.00 + UDI-DI procedure-MDR – $250 $250.00 + Validation Monitoring Procedure-IVDR – $250 $250.00 + Validation Monitoring Procedure-MDR – $250 $250.00 + Vigilance Procedure-EU_Mfg.-MDR – $250 $250.00 + Vigilance Procedure-IVDR – $250 $250.00 + Vigilance Training – $300 $300.00 + Vigilance, Distributor – $250 $250.00 + Vigilance, Importer – $250 $250.00 +
