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Regulatory Process for Product Registration, Technical File Documentation and Europe’s Proposed New Regulations on Medical Devices
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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
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