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Technical DOCUMENTATION

MDR Technical File

Risk Management

ETO Sterilization

Packaging Validation

Software Validation

Usability Engineering

Cybersecurity

Clinical Evaluation

HONG KONG

17/F, Chung Pont Com. Bldg.
300 Hennessy Road, Wanchai, Hong Kong
Off: (852) 2893-3118
Fax: (852) 2893-0863

TAIWAN

8/F-1, No. 80, Zhouzi Street,
Neihu District, Taipei City 114, Taiwan
Off: (886) 02-2758-8892

CHINA

Room 3501-1A13, East Tower, Fortune Plaza, No.116, Ti Yu Dong Road, Tianhe District, Guangzhou, Guangdong, China.
Off: (86) 20-8981-5060

USA

4610 Highland Drive
Salt Lake City, UT 84117, USA
Off: (1) 801-201-1676

AUSTRALIA

Level 25, 100 Mount Street, North Sydney, NSW 2060,
Australia
Off: (61) 2-9959-2400

UK

Unit 808, 54 Bloomfield Avenue,
Belfast, BT5 5AD, Northern Ireland,
United Kingdom.
Off: (44) 743-439-9728

Only HK office is a certified ISO 13485 site; others are business correspondence addresses.

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