Expedite your Medical Device Regulatory Submissions

Our templates are developed by consultants who have over 20 years of experience in the medical device industry and documentation that has been through successful audits.

Our consultants are available, should you need further assistance in completing the documentation.

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Tablet Filler – Counter IOQ
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Summary Report
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Standard Operating Procedures – SOP
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Validation Toolkit
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Validation Plan
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FAT Template
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Software as Medical Device Start-Up Template Package
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Guidance for EU MDR 2017/745 - Reusable Medical Devices (Class Ir)
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Guidance for EU MDR 2017/745 – Drug-Device combination products
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UDI Template (MDR)
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Clinical Evaluation Template
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Clinical Evaluation Guidance Document
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Guidance for EU MDR - Systems and Procedure Packs
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MDR Complete Package
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Guidance for EU MDR Software as a Medical Device (SaMD)
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CE Technical File
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Periodic Survey Update Template
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Post Market Clinical Follow Up (PMCF) Template
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Guidance for Unique Device Identifier (UDI)
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PMS PSUR PMCF Gap Assessment
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Economic Operators Gap Assessment
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IOQ for Anaerobic Cabinet
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IOQ for Incubator
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Design Transfer Protocol
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Design Validation Report
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DHF Checklist
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Shelf Life – Accelerated Aging and Real Time
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Test Method Validation Report
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Quality Assurance Plan
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Failure Mode and Effect Analysis
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Design Verification Report
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Design Transfer Plan
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Tablet Filler – Counter IOQ
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Summary Report
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Standard Operating Procedures – SOP
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Validation Toolkit
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Validation Plan
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FAT Template
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Software as Medical Device Start-Up Template Package
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Guidance for EU MDR 2017/745 - Reusable Medical Devices (Class Ir)
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Guidance for EU MDR 2017/745 – Drug-Device combination products
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UDI Template (MDR)
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Clinical Evaluation Template
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Clinical Evaluation Guidance Document
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Guidance for EU MDR - Systems and Procedure Packs
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MDR Complete Package
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Guidance for EU MDR Software as a Medical Device (SaMD)
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CE Technical File
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Periodic Survey Update Template
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Post Market Clinical Follow Up (PMCF) Template
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Guidance for Unique Device Identifier (UDI)
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PMS PSUR PMCF Gap Assessment
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Economic Operators Gap Assessment
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IOQ for Anaerobic Cabinet
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IOQ for Incubator
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Design Transfer Protocol
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Design Validation Report
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DHF Checklist
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Shelf Life – Accelerated Aging and Real Time
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Test Method Validation Report
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Quality Assurance Plan
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Failure Mode and Effect Analysis
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Design Verification Report
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Design Transfer Plan
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Tablet Filler – Counter IOQ
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Summary Report
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Standard Operating Procedures – SOP
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Validation Toolkit
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Validation Plan
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FAT Template
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Software as Medical Device Start-Up Template Package
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Guidance for EU MDR 2017/745 - Reusable Medical Devices (Class Ir)
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Guidance for EU MDR 2017/745 – Drug-Device combination products
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UDI Template (MDR)
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Clinical Evaluation Template
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Clinical Evaluation Guidance Document
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Guidance for EU MDR - Systems and Procedure Packs
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MDR Complete Package
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Guidance for EU MDR Software as a Medical Device (SaMD)
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CE Technical File
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Periodic Survey Update Template
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Post Market Clinical Follow Up (PMCF) Template
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Guidance for Unique Device Identifier (UDI)
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PMS PSUR PMCF Gap Assessment
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Economic Operators Gap Assessment
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IOQ for Anaerobic Cabinet
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IOQ for Incubator
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Design Transfer Protocol
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Design Validation Report
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DHF Checklist
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Shelf Life – Accelerated Aging and Real Time
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Test Method Validation Report
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Quality Assurance Plan
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Failure Mode and Effect Analysis
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Design Verification Report
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Design Transfer Plan