Contract Manufacturing Organization
Focused on the Medical market, our expertise includes manufacturing of medical devices and combination products, in vitro diagnostic test kits, and solutions for medical surgical products. We engage early with our medical customers during the design and development phase and continue throughout the entire lifecycle of the product. We offer more than electronics - we offer full medical manufacturing solutions.
Learn what Kimball Electronics
can do for you.
Watch our video below to get a view inside our Contract Manufacturing Organization facilities and check out our automation and Industry 4.0 technologies.
Engineering, Design & Development - Engaging with our integrated design and manufacturing services team increases speed to market.
Prototyping - We provide a dedicated team and equipment to expedite the process and bring products to market faster.
New Product Introduction or Transfer of Existing Product - We have a robust New Product Introduction process, focused on manufacturability. Our Transfer of Existing Product process can be applied to move product from current supplier to a Kimball facility.
Manufacturing - Choosing us to manufacture your product means you are getting a true partner. We work as an extension of your own team and we treat your product like it's our product.
Testing - We can focus on identified areas or testing criteria to validate customer concerns or to reaffirm the reliability of specific functionality. No matter what testing you need, we've got it covered.
Support and Aftermarket Support Services - We know the market can change. We create custom solutions to support our customers and their product lifecycle from start to finish.
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Capabilities:
Services:
Driven by our customer's needs and expectations, Kimball Electronics facilities and processes have met extensive industry certifications, regulatory registrations, and compliancy levels. Highlights of these include:
FDA Class I & II Manufacturing
- FDA Certified Facilities
- FDA 21 CFR Parts 820, 210, 211, 4, 11 and 901
- FDA Registered with the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER)ISO 9001 Certification
- ISO 13485 Certification
- ISO 14001 Certification
- ISO 45001 Certification
- ISO 50001 Certification
- ISO Class 8 Clean Room
- UL®, CSA®, RoHS, WEEE Regulatory Compliance and Labeling
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