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Regulatory Trends in German Bone Mineral Density Solutions, 2018 Report - ResearchAndMarkets.com

November 20, 2018

DUBLIN--(BUSINESS WIRE)--Nov 20, 2018--The “Regulatory Trends in German Bone Mineral Density Solutions, 2017” report has been added to ResearchAndMarkets.com’s offering.

The 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?

Key Topics Covered:

Research 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 Conformit Europene (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

Appendix

For more information about this report visit https://www.researchandmarkets.com/research/kn92nc/regulatory_trends?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20181120005615/en/

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Related Topics:Metals and Minerals

KEYWORD: EUROPE GERMANY

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 11/20/2018 12:33 PM/DISC: 11/20/2018 12:33 PM

http://www.businesswire.com/news/home/20181120005615/en

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