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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)

UDI Template (MDR)

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The new European medical device regulations, EU…
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Clinical Evaluation Template

Clinical Evaluation Template

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Clinical Evaluation Guidance Document

Clinical Evaluation Guidance Document

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Guidance for EU MDR - Systems and Procedure Packs
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MDR Complete Package

MDR Complete Package

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Download our complete MDR package with checklists/…
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Guidance for EU MDR Software as a Medical Device (SaMD)
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CE Technical File

CE Technical File

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Periodic Survey Update Template

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)

Guidance for Unique Device Identifier (UDI)

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This template gives guidelines to the manufacturer…
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PMS PSUR PMCF Gap Assessment

PMS PSUR PMCF Gap Assessment

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Economic Operators Gap Assessment

Economic Operators Gap Assessment

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IOQ for Anaerobic Cabinet
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IOQ for Incubator

IOQ for Incubator

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The IOQ (Installation Operational and Qualification) for…
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Design Transfer Protocol

Design Transfer Protocol

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The design transfer report documents the activities…
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Design Validation Report

Design Validation Report

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DHF Checklist

DHF Checklist

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The DHF checklist will help your 510K…
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Shelf Life – Accelerated Aging and Real Time
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Test Method Validation Report

Test Method Validation Report

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Quality Assurance Plan

Quality Assurance Plan

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Failure Mode and Effect Analysis

Failure Mode and Effect Analysis

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Design Verification Report

Design Verification Report

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Design Transfer Plan

Design Transfer Plan

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Design Traceability Matrix

Design Traceability Matrix

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Design Inputs

Design Inputs

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Design and Development Plan

Design and Development Plan

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The design and development plan simplify the…
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Design Validation Protocol

Design Validation Protocol

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The design validation protocol is used to…