The medical industry is a core competency for Barn Technologies. As an established medical devices manufacturer, we understand the complexities of this industry as well as many regulations and compliance requirements. We are ISO 13485 and ISO 9001 certified for quality management and support medical device OEMs with a wide variety of medical contract manufacturing and design capabilities.
Certified to the world's most recognized medical device standard - ISO 13485 Medical Devices
Device Contract Manufacturing
Barn Technologies provides low volume/high mix and high volume/low mix healthcare equipment manufacturing. We support medical device OEMs with a diverse range of flexible manufacturing capabilities, including:
- PCB Assembly
- SMT Assembly
- Through-Hole Assembly
- Cable & Harness Assembly
- System Builds
- Electro-Mechanical Assembly
We offer both custom solutions and solutions based on common medical hardware standards such as AMC, aTCA, and PCIe. We specialize in processor boards and high performance connectivity products for data and telecommunication solutions. We design and manufacture our products with the knowledge of what is important to the medical industry:
- We select out components with long product life cycles
- We design to the strict standards required by the medical industry (IEC 60601, ISO 80601)
- We manufacture high reliability and high quality products designed and tested to the specific application.
- Certified manufacturing facilities meeting the quality and documentation standards required by governmental regulatory agencies for manufacture of medical devices (ISO 13485).
- We provide manufacturing SOPs, test plans, certificates of conformance, PCN plans, and product line safety tests.
- We maintain device history records (DHR) for each major component as specified by the requirements of the customer.
Embedded medical platforms depend upon sub-system quality, reliability, and long-life availability. Our single board computers, embedded motherboards and backplanes are designed and manufactured in our own ISO 13485:2003 and 9001:2008 certified facilities.
We are dedicated to the medical embedded market, meeting the requirements of today’s medical products by designing and manufacturing state of the art technology.