Medical Device Development & Manufacturing
Regulatory-aware engineering from concept through production
ISO 13485–compliant medical device manufacturer
End-to-End Medical Device Development and Manufacturing
RF Kinetics provides end-to-end medical device development and manufacturing for startups, OEMs, and strategic partners. As an ISO 13485–compliant medical device manufacturer, we support the full product lifecycle, from early concept and engineering through verification, validation, and production readiness.
Our development approach integrates regulatory awareness, hands-on engineering, and real manufacturing infrastructure to reduce risk, preserve design intent, and accelerate time to market for regulated medical devices.
Engineering Built for Regulatory and Quality Compliance
Medical device development requires more than technical expertise. It demands a quality system designed for regulated products and disciplined execution at every stage of design and manufacturing.
RF Kinetics operates under an ISO 13485–compliant quality management system, with engineering and manufacturing processes aligned to FDA design controls and applicable international standards.
By integrating regulatory and quality considerations early, we help prevent costly redesigns, late-stage delays, and unnecessary regulatory risk.
Medical Device Product Development Capabilities
We provide comprehensive medical device product development services designed to support both innovation and regulatory success across the full development lifecycle.
• Concept development and feasibility analysis
• Mechanical, electrical, and RF engineering
• Design for manufacturability (DFM) and design for assembly (DFA)
• Prototype development and iterative refinement
• Verification and validation (V&V) planning and execution
• Risk management and design controls aligned with ISO 13485 requirements
• Technical documentation and design history file (DHF) support
Our engineering teams work closely with manufacturing to ensure designs are practical, scalable, and aligned with real-world production requirements.
Manufacturing Capability That Extends Beyond Design
RF Kinetics is not a design-only firm. We support the transition from development to production by providing manufacturing-focused engineering and production readiness support for regulated medical devices.
Our manufacturing capabilities help bridge the gap between prototype and scalable production, supporting pilot builds, tooling coordination, supplier qualification, and process refinement. This integrated development-and-manufacturing approach minimizes handoff risk, preserves design intent, and supports efficient commercialization.
Why Medical Device Companies Partner with RF Kinetics
Medical device companies choose RF Kinetics for our ability to combine engineering rigor, regulatory awareness, and manufacturing execution within a single organization.
• ISO 13485–compliant medical device manufacturer
• Integrated development and manufacturing expertise
• Regulatory-aware engineering processes
• Scalable support from prototype through production
• Experience with RF-based and electrosurgical technologies
• Global manufacturing and supply-chain experience
Who We Work With
We support a wide range of medical device organizations across different stages of development and commercialization, including:
• Medical device startups and innovators
• Established OEMs expanding or refining product lines
• Companies preparing for FDA submission
• Organizations transitioning from prototype to production
Start Your Medical Device Project
If you are developing a regulated medical device and require engineering, manufacturing, or scale-up support, RF Kinetics can help guide your project from concept through production.