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Regulatory Trends in German Bone Mineral Density Solutions, 2017
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
30-Oct-2018
Europe
$1,500.00
Special Price $1,125.00 save 25 %
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
Methodology
Key Findings
Scope
Key Questions this Study will Answer
European Conformité Européene (CE) Marking—Regulatory Process for Medical Devices
Technical File Documentation
Registration of Medical Device in Germany
Osteoporosis Diagnosis and Bone Mineral Density (BMD) Measurement
Germany—Prevalence of Osteoporosis, Fracture Incidence Data and Recommended Young Adult Mean (YAM)
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)
Europe’s New Regulations on Medical Devices
Europe’s New Regulations on Medical Devices (continued)
Legal Disclaimer
List of Exhibits
The Frost & Sullivan Story
Value Proposition—Future of Your Company & Career
Global Perspective
Industry Convergence
360º Research Perspective
Implementation Excellence
Our Blue Ocean Strategy
Related Research
Popular Topics
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?
| No Index | No |
|---|---|
| Podcast | No |
| Author | Srikanth Kompalli |
| Industries | Healthcare |
| WIP Number | 9AB9-00-8D-00-00 |
| Is Prebook | No |
| GPS Codes | 9570-B1,9600-B1,9614-B1,9837-B1 |