State-of-the-art devices must often be fabricated, assembled, and packaged in high-purity clean room environments. These facilities must, in turn, be certified and accredited by the relevant regulatory bodies. Advanced medical device manufacturers must work within the constrictive infrastructure of the market to meet the customer’s requirements.
In this blog post, TT Electronics outlines our approach to manufacturing medical devices.
Advanced Medical Devices from TT Electronics
TT Electronics manufactures and supplies the underlying electronics equipment for a broad range of advanced medical devices, which are marketed by some of the largest design firms and OEMs worldwide. The first barrier to entry to this challenging market is achieving ISO 13485 certification for medical device quality management systems. Each of our manufacturing facilities has achieved ISO 13485, which means we can provide our customers with a harmonized model for international system requirements and seamless product transfers.
Our ISO compliance is based on our commitment to innovation, customer-flexibility and delivering consistently high levels of quality with advanced clean room facilities that can be expanded and adjusted to unique project requirements. We specialize in low volume, high mix electronics with advanced CCD camera-equipped microscopes for extremely precise manual quality control and inspection.
Our core competencies in advanced medical device manufacturing include:
- Backplane assembly;
- Cable harness assembly;
- Conformal coatings, potting, and encapsulations;
- Surface-mount technology (SMT) PCBs;
- Through-hole technology (THT) PCBs;
- Full systems assembly and box-build services
This has proven instrumental in a range of advanced medical devices as varied as NMRI machines, diagnostics equipment, cardiological instruments, and more.
Our engineering-driven design processes enable us to not only optimize products but to enhance our production and packaging methodologies on a customer-to-customer basis. This stems from our manufacturing teams’ unmatched market knowledge, which is underpinned by our flexible approach to advanced medical device manufacturing. We can assist at all stages of product development, from initial manufacturing research to quality control and assurance.
Another of the hallmarks of advanced medical device manufacturing is the absolute reliance on full documentation to ensure that the supply of instrument components is consistent with the relevant regulations. We guarantee reliable documentation of all processes with industry-leading software capable of monitoring and documenting production, engineering, and manufacturing processes to ensure seamless execution of customer strategies and absolute confidence that processes have been conducted to the highest of standards. This ensures complete security of the medical device supply chain, from incoming components to fully-fabricated parts ready for assembly and distribution.
If you would like to learn more about advanced medical device manufacturing with TT Electronics, please do not hesitate to contact us.