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?
1. Research Methodology
2. Executive Summary
- Key Findings
- 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
- List of Exhibits