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Medical Device Testing Lab

Consulting Service

Preliminary Product Development Regulatory Guidance

Product Technical Requirements Review Service

Clinical Evaluation

Plant Construction Consulting

Quality Management System Construction


Domestic Registration/Global Market Access

China NMPA (CFDA)

US FDA (Listing, 510k)

EU CE

Brazil ANVISA (INMETRO, ANATEL )

Australian TGA

Canadian CMACAS

UK UKCA



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HTW Laboratory
Product Testing and Certification

Biocompatibility Testing

CE Certification

FCC Certification

CCC Certification

FDA Certification 

IoT Testing and Certification

ISO/IEC 17025 Accredited. 
CNAS.

ILAC.
GLP Laboratory.
CMA.
A2LA.

CBTL.

FDA certification

HTW lab provide professional FDA Approval services(including FDA 510K registration and FDA listing ) with competitive price that will help get your products to market faster, enabling greater sales and revenue.
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CE Certification

Such as Radio Equipment Directive, Low Voltage Directive, RoHS Directive, EMC Directive, Medical Device Directive, Medical Device Regulation, IVDR, Toy Safety Directive
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Medical Device Testing

HTW Lab can guide you through the testing process step by step for your medical device products, and help you meet regulatory standards for global market access.
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Biocompatibility Testing

We evaluate the biocompatibility of your medical devices in line with ISO 10993. Risk based selection of required tests, preparation of a final report.
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