Frost & Sullivan Research Service   Published: 30 Oct 2018
Regulatory Trends in German Bone Mineral Density Solutions, 2017
  SERVICE HOMEPAGE
FURTHER INFORMATION
  Table Of Contents
  1 | REGULATORY TRENDS IN GERMAN BONE MINERAL DENSITY SOLUTIONS, 2017
   Research Methodology
      1. Methodology

  Executive Summary
      1. Key Findings
      2. Scope
      3. Key Questions this Study will Answer

  DXA-BMD—Product Registration & CE Approval Process, Regulatory Requirements for Product Registration, and Technical Documentation
      1. European Conformité Européene (CE) Marking—Regulatory Process for Medical Devices
      2. Technical File Documentation
      3. Registration of Medical Device in Germany

  Osteoporosis Definitions, Bone Mineral Density (BMD) Prevalence, Incidence Overview & Recommended Young Adult Mean (YAM)
      1. Osteoporosis Diagnosis and Bone Mineral Density (BMD) Measurement
      2. Germany—Prevalence of Osteoporosis, Fracture Incidence Data and Recommended Young Adult Mean (YAM)

  Phantom Testing—Device Calibrations and Quality Check (QC) Procedural Functionalities
      1. Phantom Testing
      2. Key Quality Control Tests for DXA-BMD Devices
      3. Documentation Needs/Equipment Specification for DXA Bone Densitometer
      4. Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)
      5. Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)
      6. Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

  Proposed Europe’s New Regulations on Medical Devices
      1. Europe’s New Regulations on Medical Devices
      2. Europe’s New Regulations on Medical Devices (continued)
      3. Legal Disclaimer

  Appendix
      1. List of Exhibits

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