OUR SERVICES
Supplier quality, medical-device QMSR, cross-company quality systems, and manufacturing-program support across Asia. We are your on-site team in China and Southeast Asia.
MEDICAL DEVICE QMSR & DESIGN TRANSFER
For U.S. specification developers and finished-device manufacturers using Asian contract manufacturers: responsibilities follow the operations and authority each party actually holds. We map the establishment roles, design authority, approvals and records before we define the quality program.
Where the Asian manufacturer owns the underlying design or the U.S. company is operating under a private-label arrangement, we first establish the actual regulatory roles and record ownership before defining the program.
Where this differs from an audit: an audit tells you what the factory is doing. This work establishes who owns what between the two companies, and closes the evidence gaps on both sides.
What the engagement covers:
- QMSR and ISO 13485 evidence mapping, with a legacy Part 820 crosswalk
- Regulatory-role, design-authority, and shared/private record boundary
- Design file structure and risk-to-verification traceability
- Specification-owner and factory responsibility matrix
- Design transfer, process validation, and audit readiness
Programs: Regulatory Role & Record Ownership Diagnostic · QMSR Diagnostic · Design Transfer · Audit Readiness · Managed Supplier Quality
CROSS-COMPANY eQMS & MANAGED QUALITY
The EquatorOps Platform creates the approved quality record at the boundary between the specification owner and manufacturer. Each party retains its private commercial and proprietary records, while AsianOPS can administer the shared workspace and lead China-side execution.
- Shared quality record across specification owner and manufacturer
- Party-private and shared data boundaries
- Controlled documents and design files
- Bilateral change approvals and electronic signatures
- Complaints, NCR, CAPA and management review
- Audit binder and evidence exports
- AsianOPS administration and China-side execution
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.
Frameworks and applicable requirements we assess against:
- Supplier audits against ISO 13485:2016 and applicable QMSR requirements
- IATF 16949 (Automotive Quality - valued for rigorous process control)
- ISO 9001 (General Quality Management)
- Supplier audits against applicable GMP requirements
- ...and any quality system relevant to your industry
Our approach:
- Cross-functional quality expert teams
- Comprehensive audit reports with actionable findings
AUTOMATED FDA STATUS MONITORING NEW
Automated FDA regulatory status monitoring: a supplier's public regulatory standing can change overnight. Our Facility Compliance Engine checks FDA databases weekly rather than annually, so a lapse surfaces before it reaches your dock.
Why monitor continuously? Catch registration lapses, import alerts, and fee arrears before they disrupt your supply chain. These are public status signals that indicate supplier or shipment risk. They complement supplier qualification and quality-system auditing rather than replacing either.
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
Supplier audits against ISO 13485:2016 and applicable QMSR requirements for medical device manufacturers. Class I, II, and III device suppliers. Experience: IRRAS (Class III), Tria Beauty (Class II handheld laser).
PHARMACEUTICAL & BIOTECH
Supplier audits against applicable GMP requirements 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