MedTech manufacturing services
High-reliability medical technology. Manufactured in Sydney.
Get in touchOur MedTech manufacturing services
Circuitwise delivers advanced electronic assembly services for medical devices, certified under ISO 13485.
Our services include:
- Printed Circuit Board Assembly (PCBA)
- box-build product assembly
- testing services
- product development with ISO 13485-certified partners.
Our ISO 13485 certification
Circuitwise maintains robust systems aligned with the ISO 13485 framework, including:
Documentation
Our controlled document management system captures and stores each step of the process, from customer requirements through to final test reports.
Management responsibility
Our leadership team builds a quality-focused culture and maintains systems to support high-performance electronics manufacturing.
Production and service provision
We document, define, and control every process required to produce a medical-grade electronic assembly that meets the highest industry standards.
Monitoring and measurement
Our inspection and testing systems reduce defects, address non-conformities, and keep all equipment in top condition.
Circuitwise also holds Establishment Registration in the FDA’s FURLS database, streamlining the export of MedTech products to the United States.
Our traceability systems
Our Cluso inventory system tracks each component from supplier through to final inspection. You receive full traceability data for your device history file.
Industry participation
Circuitwise actively supports the growth of Australia’s MedTech sector through industry engagement and education.
