OUR SERVICES
Mitigate Risk in Your Supply Chain. We are your on-site experts for supplier quality, compliance, supply chain, and engineering in China and Southeast Asia.
SUPPLIER AUDITS
Core Expertise: Gain confidence in your overseas manufacturing with our rigorous on-site supplier audits, ensuring your partners in China and Southeast Asia meet the highest quality and regulatory standards.
Why trust our audits? Because we aren't just auditors—we are manufacturers. Our team operates its own ISO 9001 certified facilities through BOMQuote.com, giving us unparalleled, firsthand knowledge of the quality systems, manufacturing processes, and regulatory hurdles you face.
Quality systems we evaluate and verify:
- ISO 13485 (Medical Devices)
- FDA 21 CFR Part 820 (QSR)
- IATF 16949 (Automotive Quality - valued for rigorous process control)
- ISO 9001 (General Quality Management)
- GMP (Good Manufacturing Practice for Pharmaceutical Components)
- ...and any quality system relevant to your industry
Our approach:
- Cross-functional quality expert teams
- Comprehensive audit reports with actionable findings
AUTOMATED COMPLIANCE MONITORING NEW
Continuous FDA Compliance Verification: Your supplier's compliance status can change overnight. Our Facility Compliance Engine runs automated checks against FDA databases weekly—not annually.
Why continuous monitoring? Catch registration lapses, import alerts, and fee arrears before they disrupt your supply chain. Whether you're sourcing OTC drugs or Class III devices, we verify compliance status before every PO.
What we monitor:
- FDA Establishment Registration (FEI Status)
- FDA Import Alerts (the "Red List")
- OMUFA Fee Status (Drug Suppliers)
- Device Listing & ISO 13485 Tracking (Device Suppliers)
COMPLEMENTARY SERVICES
Supporting your audit program with additional expertise
QUALITY ASSURANCE
Maintain Excellence Post-Audit
Ongoing quality monitoring programs. Process capability studies. Corrective action verification. Continuous improvement support.
SUPPLIER SOURCING
Find and Vet Qualified Partners
Identify and vet qualified suppliers in China. Pre-audit supplier assessments. Technical sourcing for medical device and pharmaceutical components.
ENGINEERING SUPPORT
Technical Expertise On-the-Ground
Technical liaison with suppliers. Design for manufacturability reviews. Process validation support. Tooling and equipment qualification. Mechanical, electronic, and firmware design services.
LOGISTICS COORDINATION
Seamless Supply Chain Operations
Shipment coordination and tracking. Warehouse audits. Inventory management verification. Cold chain compliance for temperature-sensitive products.
STRATEGIC PROGRAMS
Enterprise support that complements our audit practice
ASSESSMENTS
Make Informed Supplier Decisions
Supplier capability assessments for pre-qualification, due diligence, and problem investigation. Evaluate technical capabilities, financial health, and operational readiness.
STRUCTURED SELECTIONS
Choose the Right Partners
Solving complex supplier selection decisions. We help you choose contract manufacturers, outsourcing partners, or distributors in SE Asia using structured evaluation frameworks.
ENGINEERING, NPI & TRANSITION
From Design to Production
On-the-ground support for DFM, CAD, electronics, technical sourcing, prototyping, fixtures & tooling, supplier qualification, and ramp-to-production transitions.
PROGRAM MANAGEMENT
End-to-End Oversight
Cross-functional leadership from supplier selection through cut-over, ensuring engineering, quality, and logistics stay aligned.
OPERATIONS EXCELLENCE
Eliminate Waste and Boost Efficiency
Lean and Six Sigma based improvements to fix inflated inventories, weak yields, long cycle-times, and other chronic waste.
QUALITY SOLUTIONS
Build Audit-Ready Systems
Transparent quality systems that reduce supply-chain risk and keep compliance programs audit-ready in regulated industries.
INDUSTRIES WE SERVE
Quality, engineering, and supply chain support across regulated and advanced hardware sectors
MEDICAL DEVICES
ISO 13485 compliant audits for medical device manufacturers. Class I, II, and III device suppliers. Experience: IRRAS (Class III), Tria Beauty (Class II handheld laser).
PHARMACEUTICAL & BIOTECH
GMP compliant supplier audits for pharmaceutical and biotechnology components and packaging. FDA and EU regulatory experience. Pharmaceutical-class goods export compliance.
CONSUMER ELECTRONICS & IoT
PCBA assembly, WiFi-enabled devices, set-top boxes, power supplies. Experience: Trend Micro (cybersecurity devices), Flight Display Systems (complex PCBA), Daily Mail (AC/DC power supplies).
BUILDING PRODUCTS & INDUSTRIAL
Electromechanical systems, BLDC motors, fluid management systems, plumbing components. Experience: Fluidmaster (2-year joint development, electromechanical toilet systems).
AEROSPACE & DEFENSE
Complex PCBA with end-of-life components, precision CNC machining, flight display systems. Expertise in strategic sourcing for specialized aerospace components.
REGULATED CONSUMER PRODUCTS
FDA-regulated vaping and e-cigarette products. Battery safety, PCBA quality, and regulatory compliance. Experience: American Vapor, Vape World, Firefly (high-end vaporizers).
Schedule Your Complimentary Consultation
Discuss your supplier audit or strategic program requirements with our team