Our Service

Providing services to local government

Undertaking medical devices enterprises risk assessments entrusted by the local government

Undertaking the regulations and standards training to medical devices industry entrusted by the local government

organizing research, investigation, and academic activities

organizing public services activities

Providing services to the industry

Consultation services for medical devices registration in China (NMPA)

Medical devices premarket clearance (domestic products & imported products) in China (NMPA)

Innovative medical devices priority approval application in China

Medical device testing application for product registration in China (Type test application and follow up)

Simulation quality system inspection for medical device registration in China

Consultation services for medical devices registration in Overseas

Medical Device registration in EU (CE)

Medical Device Registration in US FDA (510K)

Medical Device registration in other countries (e.g. Japan, ASEAN countries……) 

Consultation services for Quality Systems of medical device enterprises

Consultation services for medical device enterprises to complaint with Production quality management regulation (China GMP)

Consultation services for medical device enterprises to compliant with Sales quality management regulation (China GSP)

Application for medical device production license

Application for medical device sales license

GB/T 42061 (ISO 13485) Quality system consulting services

GB/T 42062 (ISO 14971) Risk management consulting services

US FDA QSR 820 quality system regulation consulting services

Simulation inspection

Factory construction consulting services

Cleanroom design consulting services

Process validation consulting services

Consultation in regulatory compliance during product design and development -> Technology transfer -> Registration path planning -> Quality system establishment guidance

Regulatory training

Medical device quality management system internal auditors training

Workshop for management representatives of medical device enterprises

Medical device risk management training

Professional technical training for medical devices (sterilization process / cleanroom environment / process water production, etc.)

Inspector’s capacity training on medical device testing technology (aseptic inspection, electrical safety and performance testing, etc.)

Customized in-house training for medical devices enterprises

Consultation services in Clinical evaluation

Application for high-risk medical device clinical trials

Drafting or review of clinical trial protocols/reports

Consultation for clinical evaluation of substantial equivalent products

Major services

Consultation services for building quality system according to local/international medical devices regulatory and standard requirements

Consulting and training services for medical devices registration & agency

Medical devices industry supply chain services

Medical devices industry investment and financing services

Clinical trial services for medical devices

Talent matching services

Customized services