Medical Electronics Contract Manufacturing
Medical Device Contract Manufacturing
In the strictly regulated medical device manufacturing field, you need an experienced partner with the quality management system, regulatory certifications, and knowledge of process validation necessary to fast-track your products to market.
Beyond our Quality Management System being certified to ISO 13485 and FDA registration, CO-AX is a trusted supplier to deliver assemblies and finished products worldwide.
Highly Efficient PCBAs, Final Assembly and Production of Medical Devices
We help you move from prototype to assembly to full production using a dedicated NPI line, multiple SMT lines, and the final assembly of integrated enclosures.
Every step in our process is controlled, reportable, and traceable. We proactively manage the supply chain using SiliconExpert and our proprietary tracking software.
The Supply Chain, Engineering, and Materials Teams at CO-AX work together to ensure we meet our customers’ delivery schedules. During these challenging times of parts shortages, we offer the agility and flexibility to help you Design for Availability – getting you to market as planned.
Talk to a medical device manufacturing expert
Customer Success Stories
This customer makes sleep apnea monitors for provider-managed at-home use, so the unit must be full-featured, durable, easy to use, and aesthetically pleasing.
CO-AX manufactures the PCBA for this Class II medical device and integrates all components into the final enclosure. We completed the Process Validation using pFMEA, IQ, OQ, and PQ and created the assembly work instructions.
Responding to the pandemic, we worked closely with the customer to prototype first articles then scale for full production.
How Are Medical Devices Manufactured?
The manufacturing process for medical devices involves a series of steps to design, produce, and test devices used in medical and healthcare applications. The process is highly regulated and requires adherence to strict quality and safety standards to ensure the devices are safe and effective for patients. While the specifics may vary depending on the type of medical device and the company’s manufacturing practices, the general steps involved in the manufacturing process are as follows:
The design phase produces a detailed blueprint of the device, including PCBAs, power supplies, sensors, and other components required to perform to specifications. All stages and changes must be documented in detail.
Prototyping and design for manufacturing (DFM) come next. This step ensures the device can be assembled effectively and for long-term production. Documented sign-off to move from prototyping/NPI to production is critical based on clinical trials performance.
Moving to production, PCBAs, cables, and other components are assembled and tested for functionality and quality. The design and bill of materials must be frozen at this stage in order to meet regulatory standards. Frequently companies will contract with an electronics manufacturing service provider for this phase of medical device manufacturing. CO-AX Technology utilizes IC miniaturization, micro ball grid array (BGA), and ultra-fine ball grid array (uBGA) for medical device fabrication.
In certain Class I and II medical devices, a turnkey box build is the next step in the manufacturing process. A box build integrates the various components and subassemblies into an enclosure for distribution to the market. In some cases, that “box” could be the final device, such as a home health monitoring device.
Most non-commodity Class I and II medical devices are manufactured in the United States under strict regulatory guidelines. Onshore medical device electronics manufacturers should have an ISO 13485-certified Quality Management System, FDA registration, and full traceability to comply. Read our blog, How to Choose a Medical Device Contract Manufacturer, for important insights into selecting the right partner to get your device to market.