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ASIANOPS

Our services

Engineering, technical sourcing, supplier quality, and program leadership across Asia. We help your team develop products, select capable suppliers, and carry the work through to production.

AsianOPS engineers reviewing a report in a robotics assembly lab
AsianOPS On-site expertise / Asia

Engineering & technical sourcing

Build the product. Build the supply chain.

AsianOPS leads the technical work and supplier coordination that turn a product requirement into a production program.

Design / develop / validate

Engineering & product development

Mechanical design, electronics, firmware, DFM, prototyping, tooling, and NPI. Engage our team for a technical challenge or a program from concept through manufacturing release.

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Source / qualify / develop

Technical sourcing & supplier development

Supplier searches, RFQs, capability assessments, specialized component sourcing, second-source options, and production transitions. On-site follow-through from selection to supplier readiness.

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Medical devices

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

EquatorOps platform

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

Core expertise

Supplier audits

Gain confidence in your overseas manufacturing with rigorous on-site supplier audits, ensuring your partners in China and Southeast Asia meet the highest quality and regulatory standards.

Our consulting and audit work is informed by manufacturing programs led by the AsianOPS team. Our sister manufacturing company, BOMQuote.com, operates the Shenzhen factory. That experience gives our team firsthand knowledge of supplier quality systems, manufacturing processes, and production challenges.

Our approach

  • Cross-functional quality expert teams
  • Comprehensive audit reports with actionable findings
Learn more about audits

Frameworks we assess against

  • ISO 13485:2016
  • FDA QMSR
  • IATF 16949
  • ISO 9001
  • GMP
  • 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
  • Any other quality system relevant to your industry

Automated FDA status monitoring New

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.

Learn more about compliance monitoring

What we monitor

  • FDA establishment registration (FEI status)
  • FDA import alerts (the “Red List”)
  • OMUFA fee status (drug suppliers)
  • Device listing and ISO 13485 tracking (device suppliers)

Complementary services

Practical support across your supplier program

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

Program leadership from supplier selection to production

  • 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 Southeast Asia using structured evaluation frameworks.

  • Engineering, NPI & transition

    From design to production.

    On-the-ground support for DFM, CAD, electronics, technical sourcing, prototyping, fixtures and 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 engineering, sourcing, supplier quality, or production program with our team.