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Your Contract Manufacturing

Building a medical device in-house means hiring mechanical engineers, electronics specialists, regulatory consultants, and production staff before you sell a single unit. For most companies, that’s a significant commitment before FDA clearance.

Contract manufacturing flips that equation. You get access to a full engineering team, a certified production facility, and 30+ years of combined device experience without the fixed overhead. Your capital goes into the product, not the infrastructure.

But here’s what separates a good contract manufacturer from a great one: integration. Most CDMOs don’t handle both development and manufacturing. The team that prototyped your device is not the same team that manufactures it. Details get lost. Tolerances shift. Timelines slip. Responsibilities are unclear.

At Kii.am, the same engineers who design your product also oversee its production. One team, one facility, zero translation errors.

What We Manufacture

Small, complex handheld and desktop medical devices

We specialize in devices that involve LEDs, optics, custom electronics, or precision mechanical assemblies. Our capabilities span the full development cycle:

• Concept Design and Ideation. Product architecture, requirements specification, design-for-manufacturing analysis. We start with your idea and turn it into a buildable, certifiable device.

• Rapid Prototyping. Alpha proof-of-concept and beta presentable prototypes. 3D printing, CNC machining, and early-stage functional testing to validate your design before committing to tooling.

• Electronics and PCB Design. Custom LED driver circuits, battery management systems, firmware development, and PCB layout. Our electronics team has designed power systems for devices ranging from dental curing lights to wound-healing phototherapy units.

• Regulatory Compliance Support. FDA 510(k) pre-market notification, CE marking documentation, photobiological safety testing, and biocompatibility assessments.

• Serial Manufacturing. In-house production up to tens of thousands of units per year. PCB assembly, LED integration, plastic and metal part assembly, quality inspection, packaging, and global shipping.

• Post-Production Support. Ongoing quality monitoring, design iterations based on field feedback, spare parts management, and technical support.

Quality and Compliance

Built into the process, not added afterward

Every device we manufacture follows a documented quality process. From incoming component inspection to final device testing, each step is traceable and controlled.

• ISO 13485-aligned quality management practices
• Design controls maintained from project initiation through production
• Risk management per ISO 14971 integrated into design decisions
• Full traceability from raw materials to finished device
• Testing and validation at every stage: component, sub-assembly, and finished device

When your device needs FDA 510(k) clearance or CE marking, the engineering documentation and quality records are already in order.

Frequently Asked Questions

What does Kii.am mean by contract manufacturing?

At Kii.am, contract manufacturing means integrated engineering and production. We do not just build to your specifications - we can develop the device with you from concept, then manufacture it in the same facility with the same team.

What production volumes does Kii.am support?

We handle production volumes from hundreds to tens of thousands of units per year. Our facility is set up for complex, precision medical devices rather than high-volume commodity manufacturing.

Does Kii.am handle both development and manufacturing?

Yes - that is our core differentiator. Most CDMOs do not handle both development and manufacturing. At Kii.am, one team handles everything from concept design through serial production. No handoffs, no lost context.

What types of products can Kii.am manufacture?

We specialize in complex handheld and desktop medical devices involving LEDs, optics, custom electronics, battery management, DC motors, water controls, pumps, bluetooth, touchscreens, and precision mechanical assemblies.

How does Kii.am ensure quality in manufacturing?

Our quality processes are aligned with ISO 13485. Every device undergoes incoming inspection, in-process verification, and final functional testing against defined acceptance criteria before shipping. Full traceability is maintained from component sourcing through finished device.

One team. One facility. Concept to production.

If you are developing a medical device and need a partner who handles engineering and manufacturing as one integrated process, we’d like to understand your project. Our engineering capabilities span LED optics, custom electronics, battery management, mechanical design, firmware, industrial design, and serial manufacturing.

Browse our project showcase to see examples of what we build, or get in touch to discuss your device concept.