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Keystone Solutions Group

Keystone Solutions Group is an ISO13485:2016 certified, FDA registered product development and medical device contract manufacturing company located in Southwest Michigan. In operation for over 22 years, we collaborate with customers around the world in the medical device industry to design, develop, test, and manufacture a wide range of products. Keystone provides assembly, kitting, packaging, and sterilization management services for single-use disposable and reusable medical products.

Capabilities, Infrastructure, and Impact Areas

• Multiple Class 8 clean rooms and controlled environments
• Device assembly, kitting, and packaging
• Sterile barrier packaging expertise
• Band, bar, vacuum, and form fill seal packaging capabilities
• Plastic laser welding
• Wound care, diagnostic devices, imaging products, orthopedic systems
• Class I and Class II device development and manufacturing
• 81,000 sqft state of the art facility
• 17,000 sqft dedicated Product Development Center
• Design, development, prototyping, IP strategy, and regulatory advising
• Contract manufacturing, warehousing and distribution
• Creative business models ranging from contract manufacturing to private label arrangements

Overview Statement

Website Links:

Contact Information:
Jim Medsker – Principal

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    Companies must be generating revenue in the design, engineering, manufacturing or distribution of medical devices and be located in West Michigan.

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