OUR SERVICES
Comprehensive audit, quality, and technical supply-chain services for medtech, pharma, and advanced hardware companies.
15+ Years Experience • Serving Clients Since 2010 • ISO Quality Standards
- 15+ Years Experience
- Serving Clients Since 2010
- ISO Quality Standards
SUPPLIER AUDITS
Comprehensive on-site verification of supplier quality systems by cross-functional expert teams. We audit engineering processes, quality systems, materials management, purchasing/accounting, and validation protocols. ISO 13485, IATF 16949, FDA QSR, and GMP compliance expertise for medical device, advanced hardware, and pharmaceutical suppliers across China and Southeast Asia.
QUALITY ASSURANCE
Ongoing quality monitoring programs, process capability studies, and corrective action verification. We help suppliers maintain compliance with design specifications, regulatory requirements, and quality system standards through continuous improvement support and lean/Six Sigma methodologies.
SUPPLY CHAIN SUPPORT
Engineering support, technical sourcing, and logistics coordination that extends beyond audits. From component shortage solutions (BLDC motors, sensors, converters) to NPI/transition management, supplier qualification, and warehouse/cold chain compliance, we provide comprehensive supply chain support for complex Asia sourcing programs.
MEDICAL DEVICE CLIENT EXAMPLES
Supporting compliance and manufacturing programs for Class II and Class III devices
IRRAS AB
Class III Neurosurgical Device
Multi-year supplier audit program for intracranial drainage system manufacturers in China. Annual ISO 13485 and FDA QSR compliance verification for critical molding and component suppliers.
TRIA BEAUTY
Class II Handheld Laser Device
CM transition and manufacturing ramp from in-house production in Pleasanton, CA to medical device-focused contract manufacturer in Shenzhen, China. Program management through EVT, DVT, PVT to mass production.
BIOSENSICS
FDA-Listed Wearable Device
Plastic enclosure design and manufacturing for BalanSens wearable balance assessment device. Direct procurement from our BOMQuote.com manufacturing facility for tooling and FDA-listed medical device housing components.
WHY CHOOSE ASIANOPS
Four key advantages that set us apart
DUAL PRESENCE: ASIA & NORTH AMERICA
Physical offices in Shenzhen and Orange County, CA provide on-the-ground access to suppliers across Southeast Asia while bridging the gap with your North American team.
INDUSTRY & TECHNICAL EXPERTISE
Deep knowledge of medical device regulations (ISO 13485, FDA) and pharmaceutical/biotech quality requirements, along with custom product manufacturing techniques including mechanical, electronic, and firmware.
CROSS-FUNCTIONAL EXPERTS
Cross-functional quality system experts covering engineering, documentation controls, and warehouse operations for comprehensive audit coverage.
MANUFACTURING CREDIBILITY
What sets us apart: We run ISO 9001 certified factory systems through BOMQuote.com and have successfully passed third-party audits by SGS (ISO 9001), Walmart (Responsible Sourcing), and Deloitte (Apple MFi).
TRUSTED BY LEADING BRANDS
Partner companies across medical devices, consumer electronics, building products, and regulated industries
From medical device manufacturers to hardware startups, we've supported quality programs and manufacturing operations for diverse clients.
Industries: Medical Devices • Pharmaceutical/Biotech • Electronics & IoT • Aerospace & Defense • Building Products & Industrial • Regulated Consumer Products
Plus confidential clients across aerospace, consumer electronics, and building products
SERVING NORTH AMERICA
U.S. Headquarters: Orange County, California
With our Orange County headquarters serving the Southern California medical device and pharmaceutical community within driving distance, we combine local accessibility with our Asia-based expertise. Whether you're in Southern California or across North America, we're positioned to support your supplier quality, engineering, technical supply chain, and program management needs.
SHENZHEN OFFICE
4F, Bldg. B
Heng Yu Science & Tech Park
Shenzhen, China
HONG KONG OFFICE
Unit C, 8F
Charmhill Center
TST, Kowloon, Hong Kong
CALIFORNIA OFFICE
Mission Viejo, CA
Orange County
United States
READY TO ENSURE SUPPLIER COMPLIANCE?
Contact us to discuss your audit requirements and receive a customized quote.