Beijing BIORAY Medical Technology Co, Ltd., under the brand “Beauty & Health”, is committed to providing full life cycle compliance services for global medical device companies and products. B&H focuses on helping clients achieve product compliance. With over 20 years of industry experience, we integrate resources from the entire industry ecosystem to provide full lifecycle services for medical device-related companies, including market access planning, quality management system establishment, registration guidance, clinical trials, and post-market guidance. To date, B&H has provided professional compliance services to over 30 countries and regions worldwide, and has completed over 1000 projects in various medical device sections with success.
1 Registration Services for Domestic/Imported Medical Devices Medical device categories: Class I, Class II, Class III Innovation review and priority review & approval Product testing 2 International Registration Services FDA registration CE certification Registration and regulatory services in other countries 3 Clinical Services Clinical feasibility assessment Clinical evaluation Clinical research 4 Quality System Services Consulting services for medical device production quality management system (GMP) Consulting services for ISO13485& QSR820 quality management systems MDSAP consulting services Consulting services for medical device production/operation license application 5 Usability Testing Services Human factors engineering scheme designing Formative testing Summative testing