EPINTEK GROUP

EPINTEK GROUP
A professional medical device technology platform providing end-to-end solutions for the global healthcare sector. We support manufacturers and research institutes across fast-growing medical device and biomedical markets with integrated services from R&D to regulatory clearance.

Preclinical Research and Testing

Regulation & Registration

Preclinical Animal Trail

Clinical Trial

Core Business

Foster Collaboration with Innovative Solutions

We provide services such as base screening, scheme design, initiation training, data management, biostatistics, clinical monitoring, and third-party inspection for your medical devices (including IVDs).

Clinical Trial

Preclinical Research and Testing

Provide preclinical animal experiments, biocompatibility, microbiology and other preclinical validation services

Regulation & Registration

Collaborate with partners to provide comprehensive capabilities and

innovative technologies for the medical testing industry

Services and Solutions

Class II, III, and innovative medical devices that require clinical trials, including active, passive, implantable, IVD, and other devices.

Preclinical Animal Trail

We provide services such as consultation on the compilation of technical documents, consultation on registration and certification regulations, and training.

EPINTEK Guiyang Laboratory Achieves Major Expansio......

Extended Product Scope:
The CMA scope now comprehensively supports over 20 critical medical device categories, including:
Medical Protective Equipme......
Introduction of Wireless Coexistence test items

Introduction of Wireless Coexistence test items
Bioburden/Sterility Test/Determination of a popula......

Bioburden/Sterility Test/Determination of a population of microorganisms on products/Bacterial endotoxins test
Active medical devices Testing

Active medical devices Testing