Regulatory Trends in German Bone Mineral Density Solutions, 2017

Regulatory Trends in German Bone Mineral Density Solutions, 2017

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?

  • 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
  • Proposed Europe's New Regulations on Medical Devices
    • Europe's New Regulations on Medical Devices

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