Engineering · Supply chain · Quality
On-site engineering, supplier audits, and quality support in China and Southeast Asia. We help medical device, pharmaceutical, and advanced hardware teams move from supplier risk to production confidence.
Process validation reviewed
Incoming inspection verified
Traceability gap identified Corrective action assigned to the supplier.
Our services
For medtech, pharma, and advanced hardware companies that build with suppliers in China and Southeast Asia.
15+ years experience
· Serving clients since 2010
From product concept to production-ready design.
Design engineering, DFM, prototyping, tooling, and validation led by the AsianOPS team. We connect product development with the practical work needed for manufacturing release.
Explore engineering servicesFind capable suppliers and make the production plan work.
Technical supplier searches, component sourcing, capability assessments, qualification, and supplier development. On-site follow-through across China and Southeast Asia.
Explore technical sourcingVerify supplier systems and close the quality gaps.
Cross-functional audits, corrective action verification, process capability studies, and ongoing supplier quality support for regulated and advanced hardware programs.
Explore supplier auditsKeep engineering, suppliers, and production moving together.
Local program leadership, manufacturing transitions, action and risk tracking, logistics coordination, and operational improvement from supplier selection through production ramp-up.
Explore program supportMedical device client examples
Supplier audit program
Multi-year supplier audit program for intracranial drainage system manufacturers in China. Annual ISO 13485 and FDA quality system compliance verification for critical molding and component suppliers.
Manufacturing transition
Contract manufacturer transition and ramp, from in-house production in Pleasanton, CA to a medical device-focused contract manufacturer in Shenzhen. Program management through EVT, DVT, and PVT to mass production.
Enclosure tooling & production
Plastic enclosure design and manufacturing for the BalanSens wearable balance assessment device, with tooling and FDA-listed housing components procured directly from our BOMQuote.com manufacturing facility.
Offices in Shenzhen and Orange County, CA give us on-the-ground access to suppliers across Southeast Asia while bridging the gap with your North American team.
Deep knowledge of medical device regulations (ISO 13485, FDA) and pharmaceutical and biotech quality requirements, plus hands-on product manufacturing across mechanical, electronic, and firmware.
Quality system experts covering engineering, documentation control, and warehouse operations for comprehensive audit coverage.
We run ISO 9001 certified factory systems through BOMQuote.com and have passed third-party audits by SGS (ISO 9001), Walmart (Responsible Sourcing), and Deloitte (Apple MFi).
Partner companies across medical devices, consumer electronics, building products, and regulated industries.
Serving North America
Our Orange County office is within driving distance of the Southern California medical device and pharmaceutical community, and our teams in Shenzhen and Hong Kong are at your suppliers' doors. Wherever you are in North America, we support your supplier quality, engineering, technical supply chain, and program management needs.
Integrated with the EquatorOps platform, which powers our audit and compliance workflows. Room 301, No. 207 Longping East Road, Longgang Community, Longgang Subdistrict, Longgang District, Shenzhen, China
Unit C, 8F, Charmhill Center, Tsim Sha Tsui, Kowloon, Hong Kong
Mission Viejo, CA, Orange County, United States
Tell us what you're sourcing, developing, or improving. We'll help define the right next step.