Electronic Medical Device Manufacturers
In a fast-changing world, ongoing technological advancements contribute to the continuous research and development of medical devices and the processes of electronic medical device manufacturers. At Smart Electronics, we provide technical expertise in the engineering and manufacturing of high-quality medical devices used to diagnose and treat patients in a variety of fields. Our focus is to ensure that the manufacturing process results in the repeatable production of cutting edge technology for medical device companies in Ireland and Globally.
Our team of industry professionals and our expertise in electronic manufacturing guarantee that your medical equipment is manufactured to the highest standards. Smart Electronics ensures that our manufacturing operations are optimised, meaning we identify the best manufacturing process for your product. We understand and accommodate the specific attributes of each assembly and our team will find ways of meeting the final product design while controlling costs and maintaining quality control.
Smart Electronics has been certified to manufacture electronic medical devices under ISO 13485:2016. This is an international standard certification in quality management systems which ensures that our production of medical devices meets not only the customer needs but also the statutory and regulatory requirements.
Our Services
At Smart Electronics, we provide full turnkey services. Our highly skilled team works with a global network of manufacturers and distributors to source the right materials at the right price for each project.
Our ERP System provides full traceability of all parts and components which allows us to keep our customers informed at all stages of the product lifecycle. This helps us to provide up to date information on component obsolescence and material availability.
Our team provides several electronic contract manufacturing services for products including:
PCBA Manufacturing
Smart Electronics delivers quality Printed Circuit Board Assembly (PCBA) manufacturing. PCBs form the backbone of all major electronic products and are placed in almost all modern electronic medical devices.
From component sourcing to the end product, the Smart Electronics team ensures that the manufacturing process is covered right up to a full turnkey solution, to deliver maximum flexibility regardless of size or scale of production. This allows us to guarantee that the PCBA’s are manufactured to the highest quality whilst also providing a fast turnaround when required. We focus our knowledge and expertise on creating processes that are optimised for your device.
Production Engineering
Production Engineering is the system of creating safe and efficient processes for transforming raw materials into finished items. Essentially, it connects the Design and Manufacturing phases to produce the finished product in a timely and repeatable manner.
Our team works together to gain an understanding of the requirements for the manufacture of your medical device. Smart Electronics has a team of highly qualified professionals from a number of different engineering disciplines including Manufacturing, Process, Quality and Test.
If you are seeking manufacturing services, our team can supervise your project to ensure that there is a coherent transition when changing supplier or moving to larger-scale production. In addition to this our team can also be responsible for providing quality control, generating manufacturing procedures, technical file audits and IQ, OQ, PQ reports.
Medical Device Assembly
At Smart Electronics we already manufacture a variety of medical devices and can tailor our services to handle any manufacturing and assembly needs, from low-volume prototypes to high-volume production.
From assembling state of the art medical devices to ensuring all traceability requirements are met, you can count on us to deliver products manufactured and produced to the highest quality standards.
For more information on all of our Electronic Medical Device Manufacturing services, be sure to contact Smart Electronics today.