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Regulatory Trends in German Bone Mineral Density Solutions, 2017

Regulatory Process for Product Registration, Technical File Documentation and Europe’s Proposed New Regulations on Medical Devices

RELEASE DATE
30-Oct-2018

REGION
Europe

Research Code: 9AB9-00-8D-00-00

SKU: HC03100-EU-MR_22493

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Description
Key issues Addressed
Table of Contents
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Description

A Frost & Sullivan perspective of the German Bone Mineral Density Solutions and Regulatory Trends has been covered in this research, which highlights on:

• Product Registration & CE Approval Process in Germany
• Regulatory Requirements for Product Registration for DEXA-BMD device in Germany
• Phantom Testing – Calibrations and Quality Check for the DEXA-BMD device
• Recommended Young Adult Mean for Bone Mineral Density in Germany

Key Issues Addressed

What is the regulatory process for DXA/DEXA-BMD device to obtain CE approval?
How the registration of DEXA-BMD device is done in Germany?
What are the guidelines for phantom tests and technical file documentation?
What are the key Quality Control Tests for DEXA-BMD Devices?
What is the recommended Young Adult Mean (YAM) data for BMD measurements in Germany?
What are the key documentation needs or equipment specification for DEXA Bone Densitometer?

Table of Contents

Research Methodology

Methodology

Executive Summary

Key Findings

Scope

Key Questions this Study will Answer

DXA-BMD—Product Registration & CE Approval Process, Regulatory Requirements for Product Registration, and Technical Documentation

European Conformité Européene (CE) Marking—Regulatory Process for Medical Devices

Technical File Documentation

Registration of Medical Device in Germany

Osteoporosis Definitions, Bone Mineral Density (BMD) Prevalence, Incidence Overview & Recommended Young Adult Mean (YAM)

Osteoporosis Diagnosis and Bone Mineral Density (BMD) Measurement

Germany—Prevalence of Osteoporosis, Fracture Incidence Data and Recommended Young Adult Mean (YAM)

Phantom Testing—Device Calibrations and Quality Check (QC) Procedural Functionalities

Phantom Testing

Key Quality Control Tests for DXA-BMD Devices

Documentation Needs/Equipment Specification for DXA Bone Densitometer

Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

Proposed Europe’s New Regulations on Medical Devices

Europe’s New Regulations on Medical Devices

Europe’s New Regulations on Medical Devices (continued)

Legal Disclaimer

Appendix

List of Exhibits

The Frost & Sullivan Story

The Frost & Sullivan Story

Value Proposition—Future of Your Company & Career

Global Perspective

Industry Convergence

360º Research Perspective

Implementation Excellence

Our Blue Ocean Strategy

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