Consulting ServicesCROMedical Devices

CRO Services

CHINA MED DEVICE

Booth: 432

Clinical evaluation is one of the essential steps if western companies want to register new medical products in China. Manufacturers need to prove the safe and effective of their products as well as it meets its design goal and intended use by submitting clinical evaluation data to NMPA (CFDA). China Med Device’s experienced and local contract research organization (CRO) team specialized in providing turnkey solution for China regulatory compliance clinical evaluation data for medical device/IVD/CDx/combination product. Our team of experts has 10+ years of experience writing clinical evaluation report (CER) and conducting clinical trial (CT) to meet Chinese requirements. Our CRO service include but not limited to: 1. Clinical Pathway strategy 2. Clinical Evaluation Report Writing: 3. Overseas clinical data feasibility evaluation, differences analysis and justification, submission and follow-up 4. Complete local clinical trial implementation 5. Real World Data (RWD) Acceptance

Other product: IVD & CDx Expertise

Other product: RA Strategy & Consulting






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