Medical Device Manufacturing Services
We provide the tools you need to bring your medical device to market. Our end-to-end medical device manufacturing services provide everything you need to take your project from prototype to production.
Details
Capabilities
- Production Engineering
- PCB, Wiring & Cable Loom Manufacturing
- Medical Device Assembly
- Testing & Inspection
- Procurement & Supply Chain Management
- Aftermarket Servicing & Support
Details
Fast, flexible and reliable manufacturing solutions
Take advantage of our end-to-end manufacturing services, established supply chain, and gain easy access to global markets without having to set up a factory yourself.
Our expert knowledge of performance materials and manufacturing processes, alongside established partnerships with machining, tooling, and fabrication experts, allows us to effectively handle all your production requirements from new product introduction (NPI), sustaining engineering, and medical device assembly to aftermarket servicing and technical support.
Our Capabilities
Production Engineering (PE) acts as a bridge between the concept and product design phase and the manufacturing phase. Whether you choose pilot production or long-term manufacturing, our highly-qualified production engineers, technicians, and operators will oversee every aspect of your project to ensure a seamless transition when ramping up to volume manufacture. Even if your device has been designed by a third-party, we will liaise directly with your design authority to get a full understanding of their manufacturing requirements and timescales for completion.
PE is also responsible for technical file audits, generating manufacturing procedures and detailed works instructions, process validation (IQ/OQ/PQ), and training production operators.
Using cutting-edge surface mount technology (SMT), we can deliver maximum flexibility regardless of batch quantity, resulting in fast turnaround and proving assurance that all PCBs manufactured perform to the highest standards. However, not everything is suitable for automation – that’s why we have a skilled in-house team of through-hole technicians too.
Nowadays, many medical devices incorporate complicated wiring harnesses and cable assemblies. Our technicians have extensive experience accommodating wiring harness and cable assemblies using both semi-automatic and skilled manual processes.
We can handle any manufacturing and assembly needs, from low-volume prototypes to high-volume production. You can count on us to deliver consistent quality and performance to reduce risk and provide added security.
Your medical device will be manufactured in a dedicated production work-cell, which becomes an extension of your company within our 3,000 m2 factory. Each cell is assigned operators, approved and controlled works instructions, tools, jigs, fixtures, and testing facilities.
Our state-of-the-art automated test and inspection equipment assures that all devices manufactured to perform to the highest standards. We use Quins to capture, inspect and record high-quality images of every PCB before they are integrated into your device. For comprehensive test coverage, we use our in-house 3D automated optical inspection (AOI) system. It’s ideal for inspecting 0201 and 01005 components, 0.3 mm pitch, process control for defect prevention, and effective quality verification.
If required, we can perform a flying probe test to provide even greater coverage for complex PCB designs for a quick turnaround.
Utilizing our trusted global network of suppliers, we can source high quality and cost-effective materials and components to meet your project requirements. Using our in-house ERP system, we can track materials, parts, and components across our supply chain to provide full traceability throughout the lifecycle of your medical device.
We have established long-standing partnerships with our suppliers, built on trust, transparency, and open communication, enabling us to be proactive if notified of any proposed supplier changes.
No matter where you are in the world, we can provide global servicing and support post-manufacture. We can undertake and manage the following:
- Device installation
- Product repair
- Scheduled maintenance
- Product technical support
- Device repackaging and distribution
- Warehousing and logistics
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