EPINTEK Guiyang Laboratory Achieves Major Expansion of National CMA Ac......

Extended Product Scope:
The CMA scope now comprehensively supports over 20 critical medical device categories, including:
Medical Protective Equipment
Hygiene Materials & Medical Textiles
Anesthesia and Respiratory Circuits
Vascular and Non-Vascular Catheters
Advanced Dress......

Introduction of Wireless Coexistence test items

Introduction of Wireless Coexistence test items

Bioburden/Sterility Test/Determination of a population of microorganis......

Bioburden/Sterility Test/Determination of a population of microorganisms on products/Bacterial endotoxins test

Active medical devices Testing

Active medical devices Testing

Medical Device Cleaning Validation

Medical Device Cleaning Validation

Medical Device Sterilization Validation Services

Sterilization is a process to make products free from viable microorganisms. Some semi - critical and all critical medical devices should be sterilized before next use. Reference standards include FDA guidance, AAMI TIR 12: 2020, ISO 17664 - 1: 2021 and others. Sterilization effi......

Global Packaging Validation for Medical Devices: FDA, EU MDR & NMPA

FDA recommends package test methods include simulated distribution and aging followed by associated packaging testing to demonstrate packaging materials can maintain sterile barrier integrity during device shelf - life. Device - specific performance testing for storage effects is......

End-to-End Clinical Trial Solutions for Medical Devices: From Protocol......

The Clinical Trial Team offers comprehensive services for clinical trials of Class II, III and innovative medical devices. Services include protocol design (trial protocol, informed consent form etc.), clinical monitoring (site screening, ethical communication etc.), data managem......