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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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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Design Traceability Matrix
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Design Inputs
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Design and Development Plan
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Design Validation Protocol
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Usability Checklist
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Gap Analysis Report Template
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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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Shearer / In Line Mixer Template
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Tablet Counter IOQ Template
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Bottle Unscramblers
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URS Template (CIP system)
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IOPQ Template
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IOPQ for Cartoning Machine
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IOPQ for Laminar Air Flow
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Part 11 Remediation Plan
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IOPQ for Freezer Validation
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Blister Machine IOQ Template (without Vision System)
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Capper IOQ Template
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Garvens IOQ Checkweigher Template
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Liquid Filler IOQ
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Labelling Machine Template
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Measurement System Analysis Validation Protocol
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Validation Master Plan/Policy
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PQ Template
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OQ Template
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OPQ Template
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IOQ Template
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IQ Template