Medical Device Product Development and Manufacturing Services
Bring Your Medical Device Vision to Life
Engineering, Manufacturing and Licensing Services from Concept to Commercialization
At RF Kinetics, we partner with innovators, surgeons, and medical device companies to transform ideas into manufacturable and regulatory ready products. Our team delivers end to end product development, manufacturing, and licensing solutions tailored specifically to the medical device industry.
With decades of hands on experience and vertically integrated capabilities, we help reduce risk, shorten development timelines, and accelerate market entry.
Our Core Capabilities
Engineering and Product Development
Concept design and technical feasibility analysis
Innovative design expansion and optimization
Research and development programs
Functional and working prototypes
Design verification and validation activities
Intellectual Property and Strategy
IP preparation and development support
Design around and freedom to operate strategies
Licensing, co development, and joint venture pathways
Regulatory and Compliance Support
FDA 510(k) preparation and submission support
CE documentation support under EU MDR
China NMPA (formerly CFDA) preparation support
Design history file and technical documentation alignment
Manufacturing and Scale Up
Complete tooling development including molds, fixtures, and automation
Turn key production lines built in house or deployed at your facility
ISO compliant manufacturing workflows
OEM manufacturing programs
Clean Room Assembly and Packaging
Certified clean room assembly and packaging
Sterile and non sterile device packaging
Coordination of sterilization services
Production ready quality systems
Why RF Kinetics
Medical device focused organization
Vertically integrated research, tooling, and production
ISO compliant clean room facilities
Deep regulatory experience in the United States, Europe, and China
Flexible business models including development services, OEM supply, and licensing
Our team brings over 80 years of combined experience in medical device engineering, manufacturing, and commercialization. From early stage concepts to scaled production, we work as a true development and manufacturing partner, not simply a contract vendor.
Engagement Models
We support multiple engagement structures based on partner needs:
Fee based product development
OEM manufacturing agreements
Licensing and royalty based models
Strategic partnerships and joint ventures
Each engagement is structured to align technical execution, regulatory strategy, and commercial goals.
Let’s Talk
If you have a medical device concept, existing intellectual property, or a product ready for optimization or scale up, we welcome the opportunity to connect.
Please send over your mutual NDA and let’s discuss next steps.