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Regulatory Trends in German Bone Mineral Density Solutions, 2017

  • Report

  • 37 Pages
  • October 2018
  • Region: Germany
  • Frost & Sullivan
  • ID: 4668818

The authors 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

1. Research Methodology
2. Executive Summary
  • Key Findings
  • Scope
  • Key Questions this Study will Answer

3. 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

4. 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)

5. 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

6. Proposed Europe’s New Regulations on Medical Devices
  • Europe’s New Regulations on Medical Devices
  • Legal Disclaimer

7. Appendix
  • List of Exhibits