We provide a wide range of custom kitting, from simple to highly complex and regulatory compliant solutions.
Capabilities
ISO 13485
ISO Class 7 Clean Room
FDA Registered Facility & compliant with 21 CFR Part 820
New product development support and DFM
Ready for market packaging
IQ/OQ/PQ validation of manufacturing processes
Commercial sterilization support
“I would like to thank the team at Columbia Plastics for their experience, knowledge and effort as working as an integral part of our design team in the development and bringing to market of our key products.”
Medical device OEM $109 Million USD annual revenue
“Columbia Plastics has proven to be a very professional, superior injection molder with a high level of performance. They provided us with “peace of mind” so we could concentrate on other aspects of the project, which was very helpful to us.”
International Orthopedic OEM with $285 Million USD annual revenue