IRRAS AB
Intracranial drainage system manufacturer
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 quality system compliance
- Assessment of two critical suppliers:
- A molding and tooling shop performing integration assembly for sub-modules
- A 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 and receiving procedures.
- Detailed reporting: comprehensive audit reports with findings, risk assessments, and corrective action recommendations.
- Annual program: established a 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 a Class III medical device.
Local client, Asia expertise
Leveraged our Shenzhen office for on-the-ground access while maintaining close coordination with the San Diego-based client.
