Manufacturing
Your Medical Device Manufacturing Partner
Gentian Health has full in-house medical device manufacturing capabilities for products which require electronic and mechanical assembly.
Gentian Health has both non-clean room assembly as well as an ISO 7 Clean Room assembly and packaging capability.
Clean Room Assembly and Pack
- ISO 7 cleanroom
- Electronic and mechanical clean room assembly processes
- Pouch packing for follow-on sterilization
- Tray packaging for follow-on sterilization
- Support Design verification
- Clinical trial and Design Verification batch builds
- Continuous supply for low and medium volume requirements
- Full DMR for clinical trial batch builds
- Verification and Validation
Electronic Product Assembly
- Assembly of PCBA into product housing. (Box build)
- Flexible configurable assembly cells to support low and medium volume build requirements
- Functional test
- Ultrasonic weld sealing for plastic enclosures
- Adhesive sealing
- UV bonding
- Heat staking
- Final kit configuration
- Full DMR for Clinical trial batch builds
Printed Circuit Board Assembly (PCBA)
- In house Surface Mount Line supporting medium volume and high mix requirements
- Automated component Pick and Place
- Solder Reflow
- Automated Optical
- Inspection PCBA test
- Supporting rapid electronic design and prototype iteration Demonstration level batch build
- PCBA manufacture for Clinical trial batch builds
- Conformal coating
- PCBA Manufacture for ongoing production requirements when product launched
- Providing PCBA assemblies for integration to mechanical systems later in Gentian Health’s process
Specialised Medical Device Manufacturing Process Supporting Our Customers’
Product Development Journey
At each phase, we combine the optimal medical device manufacturing team, capabilities and technologies with high levels of client collaboration to deliver a seamless experience from project kick-off to product launch.
Certifications And Regulatory Compliance
Gentian Health is certified to the medical device standard ISO 13485 for both Design and Manufacture of electronic products. Our medical device manufacturing team has a proven track record of designing for and attaining the following certifications across a range of products and projects CE, FCC, FDA and UL.
Gentian Health’s regulatory expertise and focus on quality ensures your device will meet the highest industry standards and global compliance requirements.
