EastPoint Innovation Center Co., Ltd. is an independent third-party organization specializing in providing professional services to the medical device industry. Our core capabilities encompass preclinical animal trial research, inspection and testing, clinical research, and translation services for medical device products.

Situated in Jincheng International Science and Technology City, Yuhang National Economic Development Zone, Hangzhou City, our center was jointly founded by a team of leading figures from both Chinese and American industries and is backed by prominent investment funds in the medical device industry. With a professional technical team and cutting-edge medical device research and development testing equipment, along with a comprehensive and standardized quality management system, we operate under GLP standards and are recognized by CNAS & CMA. Our facilities include two four-story laboratories and office areas, covering approximately 10,000 square meters, establishing us as a premier one-stop platform for medical device innovation and transformation, characterized by leading domestic scale, professionalism, and functionality.

Key Advantages:

One-stop Transformation Platform: Our services span the inspection and testing of medical device products, preclinical animal trial research, human clinical research, and consulting and transformation services.

Experienced Technical Team: Our team includes founders of domestic animal experimental centers, experts with decades of experience in preclinical and clinical research of medical devices, professionals with experience commercializing innovative medical devices from top 500 companies, and contributors to the development of multiple national and industry standards. Our memebers are engaged in medical device related inspection and testing work for more than 15 years

Trustworthy Partnerships: We are committed to fostering trust among corporate organizations, governments, and individuals, aiding local and global customers in accelerating business success and enhancing sustainable competitiveness.

Core Business:

01 Medical Device Function and Safety Evaluation:

The Functional Evaluation Department is fully equipped with facilities for raising large experimental animals and primates, complemented by state-of-the-art global equipment. It is led by a distinguished research team, including internationally renowned PhDs, specializing in neurosurgery, orthopedics, cardiovascular surgery, ophthalmology, facial features, dentistry, and more. Our department's services encompass medical device treatment effects, indicator research, safety evaluation research, and preclinical trial research. We collaborate extensively with domestic and foreign regulatory authorities, industry-leading enterprises, and top-tier tertiary hospitals to offer professional technical support.

Our department features:

● Cutting-edge interventional catheters (DSA), surgery, and ophthalmic operating rooms.

● Advanced Philips Azurion 7 M20 suspended and Azurion 3 M15 flat plate vascular imaging systems.

● EPIQ CV Xi Flagship AI Cardiovascular Interventional Specialized Ultrasound System.

● IntraSight Series 5 Intravascular Ultrasound.

● Philips Ultra High-end Haoke Spectral 256 Row Spectral CT.

● Zeiss Ophthalmic Surgery Microscope for Lumera T.

● Constellation Alcon Ophthalmic Phacoemulsification and Wave Cutting Surgery System.

02  Biological Evaluation of Medical Devices:

For the biological evaluation of medical devices, we offer comprehensive facilities and services:

Independent barrier-level breeding rooms, barrier-level laboratories, and independent ordinary-level breeding rooms and laboratories.

Professional sterile testing rooms, microbiological identification rooms, and P2 level microbiological laboratories.

Inspection of toxicology, genetics, immunology, sterility performance, and microbial limits of medical devices.

Our services include biological safety evaluation of medical devices, microbiological experimental research, and disinfection control and validation.

Our facilities and equipment include:

● Barrier-level animal area and common-level animal area.

● Multi-channel heat source thermometer for accurate temperature measurements.

● Olympus fluorescence microscope for detailed observation and analysis.

● Merier bacterial identification instrument for precise identification of bacterial strains.

● Millipore membrane filtration system for microbial filtration.

● Pyors Kinetix bacterial endotoxin tester for assessing bacterial endotoxin levels

03 Laboratory Medicine and Material Analysis Testing:

The Analysis and Testing Department consists of a clinical laboratory and an analysis and testing laboratory, equipped with full process pathological equipment, blood and fluid examination equipment, and chemical analysis equipment, with the ability to analyze soft and hard tissue pathology. Clinical testing includes pathological examination, body fluid examination, etc; Material analysis testing includes material chemical characterization, leachable material analysis, and drug phase solubility analysis.

● Full process Leica NANOCUT and BIOUCUT pathological equipment, material hard tissue slice analysis capability (including polymer materials or metal tissues)

● Sysam Meikon Blood and Coagulation Analyzer

● Agilent gas chromatograph, liquid chromatograph, and gas chromatography-mass spectrometer

● Hitachi Biochemical Analyzer

● Thermo infrared spectroscopy analyzer

● Shimadzu UV visible spectrophotometer

04 Clinical Research (CRO) and Registration Consultation and System Services:

We possess efficient professional service capabilities, extensive experience in providing solutions, and a proven track record in project management, all while adhering to stringent industry standards and quality requirements. Our services encompass the entire cycle of clinical research, tailored to address various product mechanisms and clinical application scenarios. Here's what we offer:

● A clinical research and registration consulting team led by an expert level professional team

● ISO 9001 Quality Certification

● Integrated clinical research and product registration full cycle service chain

● Strategic cooperation with leading medical device CROs in Europe

05 Training and Exchange of New Medical Technologies:

Our comprehensive training center offers versatile training rooms equipped with state-of-the-art medical equipment.

We provide education, surgical demonstrations, and practical services, including live broadcasting of manual surgery, to facilitate systematic medical training.

Our service center is equipped with education and training operating rooms and video training rooms, offering refined practical training services for medical device professionals.

● 10 educational and training operating rooms operating together

● 80 person video training conference room

● Systematic clinical medical training

● Visual Window Training Guide

● On site practical training experience

Company Qualifications:

EastPoint Innovation Center Co., Ltd. boasts the largest comprehensive inventory of experimental animals in China and operates under a standardized laboratory quality management system with certifications including ISO 9001 system certification, CNAS accreditation, and CMA accreditation. Our laboratory quality management system strictly adheres to ISO 17025, ISO 9001, AAALAC specifications, and GLP system standards.