Quality Certifications
China Manufacturing Campus and HongKong Service Center

• ISO-9001:2008 by SGS
• ISO-13485 by SGS
• ISO-14001 by TUV
• OHSA-18001 by TUV

US Engineering, Logistics and Service Center

• ISO-9001:2008 by BSi

Compliant to US FDA 21CFR820 Medical Device Directive

• Successfully passed mulitiple third party audits
• Producer of 6 Class I medical devices with software
• Class II medical device capable
• On-site services to support your Design History File
• Full Traceability for all products manufactured

Manufacturing Highlights

• Over 50 medical devices or medical device sub-assemblies currently under manufacturing agreements
• On-site injection tooling, molding, painting, metal stamping, windings, PCB assembly and turnkey device assembly
• 100K (ISO 8) Clean Rooms for Molding and PCB Assembly
• Well versed in process validation protocols
• Shipping to US and European customer sites
• Warehousing in US and Europe