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

RELEASE DATE
30-Oct-2018
REGION
Europe
Research Code: 9AB9-00-8D-00-00
SKU: HC03100-EU-MR_22493

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$1,500.00

$1,125.00 save 25 %

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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
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--BEGIN PROMO--

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?
More Information
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