Ensuring Supplier Compliance for Medical Device & Pharmaceutical Companies

On-the-ground supplier audits in China & Southeast Asia. Expert verification teams ensure quality systems meet regulatory standards.

Program Management & CM Transitions

Cross-functional leaders drive DFM, supplier qualification, pilot builds, and production cut-overs to reduce COGS for regulated devices.

Operations & Quality Excellence

Lean, Six Sigma, and transparent QA programs keep suppliers audit-ready while unlocking margin across Asia supply chains.

OUR SERVICES

Comprehensive audit and quality services for regulated industries

SUPPLIER AUDITS

On-site verification of supplier quality systems with functional expertise in engineering, accounting, and warehouse management. ISO 13485 and FDA compliant.

QUALITY ASSURANCE

Continuous quality monitoring and verification programs to ensure suppliers maintain compliance with design specifications and regulatory requirements.

SUPPLY CHAIN SUPPORT

Technical sourcing, logistics coordination, and engineering support to complement your audit program and optimize supplier relationships.

WHY CHOOSE ASIANOPS

Four key advantages that set us apart

DUAL PRESENCE: ASIA & SOUTHERN CALIFORNIA

Physical offices in Shenzhen and Orange County provide on-the-ground access to suppliers across Southeast Asia while bridging the gap with your Southern California team.

INDUSTRY & TECHNICAL EXPERTISE

Deep knowledge of medical device regulations (ISO 13485, FDA) and pharmaceutical/biotech quality requirements, along with custom product manufacturing techniques (electronic/mechanical).

CROSS-FUNCTIONAL EXPERTS

Cross-functional quality system experts covering engineering, documentation controls, and warehouse operations for comprehensive audit coverage.

MANUFACTURING CREDIBILITY

We don't just audit suppliers—we run ISO 9001 certified manufacturing operations ourselves through our BOMQuote division. This insider knowledge ensures we know what supplier excellence looks like.

SERVING SOUTHERN CALIFORNIA

Orange County | Los Angeles | San Diego | Riverside

With our Mission Viejo office serving the Southern California medical device and pharmaceutical community, we combine local accessibility with our Asia-based audit expertise. Whether you're in Orange County, Los Angeles, San Diego, or Riveride, we're positioned to support your supplier quality, supply chain, and engineering programs.

READY TO ENSURE SUPPLIER COMPLIANCE?

Contact us to discuss your audit requirements and receive a customized quote.