Medical Device Development — Cleveland, Ohio
Medical Device Engineering,
Under Design Controls.
Device electronics, embedded firmware, and systems engineering executed under design controls — IEC 60601, ISO 14971 risk management, and documentation that stands up in your 510(k).
Kyros Engineering develops medical devices in Cleveland, Ohio — device electronics, embedded firmware, and systems engineering executed under design controls, with IEC 60601 compliance, ISO 14971 risk management, and verification documentation that supports FDA 510(k) submissions.
Medical Device Development in America's Med-Tech Corridor
Kyros Engineering develops medical devices from Cleveland, Ohio — minutes from one of the densest medical ecosystems in the country: the Cleveland Clinic, University Hospitals, Case Western Reserve University, and the startups of the Health-Tech Corridor. We work with device founders, clinical innovators, and established manufacturers across Northeast Ohio and nationwide.
Our engineers have delivered connected medical devices with BLE telemetry and full IEC 60601 traceability, diagnostic instruments and IVD platforms, and — across prior engineering leadership roles — Class III implantable neurostimulation systems, surgical energy devices, and 7-Tesla MRI RF hardware. That depth means your device is architected by people who have already carried products through verification, audits, and submissions.
We slot into your quality system or help you stand one up: design controls from the first sketch, risk management as a design input rather than paperwork, and verification evidence your regulatory consultant and the FDA reviewer can follow. Engagements start with a fixed-price Architecture Diagnostic that de-risks the technical path before you commit serious capital.
What We Deliver
Engineering That Survives an Audit
Device Electronics & Firmware
Sensing front ends, embedded control, BLE telemetry, and low-noise design for diagnostic and therapeutic devices.
Standards Compliance
IEC 60601-1 safety and 60601-1-2 EMC designed in from architecture — not retrofitted after a failed chamber visit.
Design Controls & Documentation
ISO 14971 risk files, FMEA, requirements traceability, and V&V evidence formatted for your DHF and submission.
Feasibility to Verification
From clinical concept and works-like prototypes through design freeze, verification builds, and transfer.
Real Project
OR Suture Counter
Prior Engineering Leadership — Operating-room device engineering under full medical design controls
Frequently Asked Questions
- Can you work under our quality management system?
- Yes. We execute inside your ISO 13485 QMS and design-control procedures, or help early-stage teams stand up right-sized design controls before their first design review.
- Do you handle FDA 510(k) submissions?
- We deliver the engineering substance of a submission — architecture, risk files, requirements traceability, and V&V evidence — and work alongside your regulatory consultant who owns the filing itself. The engineering documentation arrives submission-ready.
- Can you help before we're under design controls?
- Yes — feasibility and works-like prototypes are often the right first step. We architect them so the path into design controls is clean, rather than forcing a rebuild when the project formalizes.
- What does a medical device engagement cost?
- Engagements start with a fixed-price design review or Architecture Diagnostic ($3K–$6K) that de-risks the technical and regulatory path. Focused subsystem work typically runs $8K–$20K; full device programs are milestone-gated and quoted phase by phase as device class and evidence burden become…
Ready to Talk Through Your Build?
Tell us what you're building. We'll schedule a free consultation to discuss architecture, timeline, and budget — with an engineer, not a salesperson.
Talk to Our Founder