Your medical devices outsourcing partner specializing in implantable devices
Kinamed provides medical device industry OEM services to handle any or all phases of your device development and manufacturing requirements. Anything from simple sterile packaging to complete design engineering, manufacture and packaging services are available to meet your needs. We specialize in implantable products but can handle most types of medical devices. Our customers run the gamut from small start-ups with a product idea that choose to focus their resources on sales and marketing to very large industry leaders looking to outsource. Whether it is simply packaging and sterilizing your product or complete development and manufacture of your product, we are here to serve you.
Why choose Kinamed?
With over 100 years combined experience in implantable device design and engineering, regulatory affairs, quality assurance, manufacturing and sterile packaging validation, Kinamed’s senior staff provides the knowledge in all critical areas of device development and manufacture to insure your product gets to market successfully.
Kinamed is FDA licensed and certified to ISO 13485, Council Directive 93/42/EEC, to provide the framework that allows your product to be marketed anywhere around the world.
Some of Kinamed’s capabilities and services include:
Design
- FDA Design Control compliancy
- Materials selection
- 3D CAD capability including surface modeling and FEM analysis
- Injection mold design
- Project management
Regulatory
- Regulatory consulting
- Review or authorship of submissions
- CE Technical File consulting
Manufacture
- Precision assembly
- Plastic molding
- Articulating surface high polishing
- Bead blast, grit blast metal surface finishing
- Chemical cleaning and passivation
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