We provide expertise in front-end product development, proof of concept, regulatory strategy, and pilot production, bringing your innovation medical device product ideas from Concept to Commercialization (C2C). As a contract manufacturer, we are:
- FDA Registered
- ISO 13485:2016 certified
- Certified ISO 7 (Class 10,000) Cleanroom environment
C2C was founded with the goal to help inventors develop their concepts quickly and efficiently by getting products to market without the bureaucracy of a large company. The vast experience of the C2C team can help you successfully navigate the design challenges, regulatory requirements and production scale up of your medical device.Meet our team
As your FDA registered, ISO 134845:2016 certified Contract Manufacturer, we can manufacture, package, label and sterilize your medical device products. We specialize in low volume, manual/semi-automated assembly, and packaging of products that larger OEMs may not want to quote. Our certified ISO 7 (Class 10,000) cleanroom provides a controlled environment to ensure the cleanliness your medical devices require.
Design Services and Prototyping
C2C has extensive experience developing medical devices for several different markets including laparoscopic, endoscopic, orthopedic, intravascular, neurological, stereotactic, and for a number of drug delivery applications.
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We can assist with your intellectual property strategy, patent application and patent drawings as needed.
In addition to creating 3D computer generated models, C2C has rapid prototyping capability supported by 3D printing and both conventional and CNC machining to quickly bring your new product ideas to life. We can test, trouble shoot, and then iterate designs quickly to help speed your new product ideas to market.
C2C also has several years of process development experience that uniquely positions us to not only develop a product design but develop and validate the key manufacturing processes required to constantly produce your product with high level of quality. As contract manufacturer we can support your product as you scale manufacturing from pilot production to commercial release.
C2C can develop your product under our ISO 13485 quality system and internal Design Control Procedure, or we can work with you under your company's quality system if you prefer.
Medical Device Assembly and Packaging
From individual components and sub-assemblies to the full manufacturing and packaging of your medical device, C2C can provide you with a turn-key operation including component sourcing and procurement, inspection, kitting, cleaning, assembly, and packaging. Contact us for additional information.
C2C's network of qualified suppliers as well as an ISO 13485:2016 system for evaluating and approving suppliers ensures that materials and components are reliable, qualified, and monitored.
Verification and Validation Testing
Our Verification and Validation testing includes Packaging Seal Integrity testing, shelf-Life testing, and Mechanical/Functional testing to ensure that when your product is manufactured, it meets your specifications and requirements.
Sterilization Management and Laboratory Testing
Sterilization and laboratory testing includes protocols, sample preparation, coordinating with 3rd party contract sterilizers and laboratories, and writing final reports.
Regulatory Strategy and Submission
From initial consultation to the final preparation and submission of your regulatory documentation, C2C can assist you in attaining your regulatory clearances.