CASE STUDIES
Real-world supplier audit success stories
Our audit expertise is backed by hands-on manufacturing experience. Through BOMQuote.com, we've designed and manufactured 100+ custom products—giving us insider knowledge of supplier operations, quality systems, and manufacturing challenges.
FEATURED AUDIT CASE STUDY
IRRAS AB - Intracranial Drainage System Manufacturer
San Diego, CA | Class III Medical Device
Multi-year supplier audit program ensuring compliance for critical molding and component suppliers in China.
THE CHALLENGE
IRRAS AB manufactures an intracranial drainage system, a Class III medical device requiring the highest level of regulatory compliance. With critical suppliers located in China, IRRAS needed:
- Annual on-site audits of China-based suppliers
- Verification of ISO 13485 and FDA QSR compliance
- Assessment of two critical suppliers:
- Molding/tooling shop performing integration assembly for sub-modules
- Button pad manufacturer producing custom medical device interface components
- Comprehensive functional area coverage (engineering, quality systems, warehouse operations)
- Detailed reporting for regulatory compliance documentation
OUR SOLUTION
AsianOPS deployed cross-functional quality system experts to conduct comprehensive annual audits of both critical suppliers:
- Engineering & Quality Review: Verified molding processes, tooling controls, assembly procedures, and product quality specifications
- Quality Systems Audit: Assessed document controls, change management, CAPA systems, and regulatory compliance programs
- Operations & Warehouse: Evaluated inventory controls, lot traceability, material handling, and shipping/receiving procedures
- Detailed Reporting: Comprehensive audit reports with findings, risk assessments, and corrective action recommendations
- Annual Program: Established recurring audit schedule to maintain ongoing supplier compliance
RESULTS
Years of Successful Compliance
Multi-year audit program for China supplier quality systems ensuring regulatory compliance for Class III medical device.
Local Client, Asia Expertise
Leveraged our Shenzhen office for on-the-ground access while maintaining close coordination with San Diego-based client.
ADDITIONAL PROJECT EXPERIENCE
Supplier management and quality programs across diverse industries
TRIA BEAUTY
Class II Medical Device
Challenge: Outsource manufacturing to China for handheld laser medical device
Solution: Managed team of global directors through EVT, DVT, PVT to mass production ramp readiness
FLUIDMASTER
Building Products - SoCal Based
Project: 2-year joint development with Fluidmaster & Roca
Scope: Led NPI in China for electromechanical toilet, prototyped low voltage BLDC driven blower system
TREND MICRO
Cybersecurity Solutions
Project: Picture and video management set-top box
Scope: RFQ management to select ODM partner, negotiated pricing and NRE's, advised on key terms & MSA
FLIGHT DISPLAY SYSTEMS
Aerospace Electronics
Challenge: Strategic sourcing for blue-ray PCBA using end-of-life Broadcom SOC
Scope: Led prototyping for CNC parts, delivered precision aerospace components
NOMIKU
Kickstarter-Funded Kitchen Tech
Project: Sous vide immersion circulator ODM partner selection
Results: Advised CEO on terms & MSA, led strategic sourcing for accelerated project ramp
GOPOLE
GoPro Accessories
Manufacturing: 40+ injection molded parts, production tools, retail packaging
Products: Bobber, Grenade, Reach, EVO, Timer, ARM, Tripod, Tray, Adapters
TRUSTED BY LEADING BRANDS
Partner companies across medical devices, consumer electronics, building products, and regulated industries
From medical device manufacturers to hardware startups, we've supported quality programs and manufacturing operations for diverse clients.
Plus confidential clients across aerospace, consumer electronics, and building products
READY TO START YOUR PROJECT?
Whether you need supplier audits or end-to-end manufacturing support