We offer world-class circuit board assembly and electro-mechanical box build services to the medical industry.
Currently, a large percentage of Saline Lectronics’ business is performed for the healthcare market – assembling everything from patient heart monitors to cancer diagnostic devices. We thoroughly understand the critical nature of the medical industry, and provide thorough documentation with traceability to all of our medical customers, ensuring the medical PCB assembly will exceed manufacturing requirements and customer satisfaction demands.
Due to our continued growth in the medical and bio-medical markets, Saline Lectronics has invested in certifications that are necessary for circuit board assembly manufacturing. We are ISO13485:2016 certified and compliant to FDA CRF820 part 21, guaranteeing that we meet the necessary requirements for medical PCB assembly.
Since many of our medical electronics assembly customers now compete in a global economy, selling end products all over the world, we also hold Japan’s Good Manufacturing Practices (GMP) Certification. This is very similarly aligned to the ISO 13485, but allows us to ship directly to medical end-users in Japan. This is our first medical PCB assembly certification outside of the US, and clearly illustrates our understanding of this ever-changing, and ever-expanding medical global market.
In addition to our medical electronic assembly certifications, we are also equipped to build to IPC Class 3 where required. Our electronics manufacturing facility also supports RoHS assembly requirements, and we can also assist transitioning a Tin Lead assembly into a RoHS compliant one.
Our software management system, Cogiscan’s Track, Trace and Control (TTC) System, that is used in our production floor is incredibly beneficial to our medical PCB assembly customers. This system allows us to provide detailed traceability, all the way to the reference designator, on enrolled products. Additionally, the TTC Program further illustrates our commitment to transparency and our emphasis on full traceability.
We would genuinely love the opportunity to assist in building your medical product – please contact us to learn more about our healthcare services.