Medical Device & Embedded
Electronics Engineering in Pittsburgh
SiGenix is a Pittsburgh-based engineering firm with over 20 years of experience designing medical devices, embedded systems, and power electronics. From schematic capture through 510(k) submission, we deliver hardware and firmware that ships.
What We Do
Deep expertise across the full stack
Our work spans FDA-regulated medical devices developed under IEC 62304 and IEC 60601-1, ultra-low-power STM32 firmware for battery-powered devices, custom switching power supplies, multi-layer PCB design, and full EMI/EMC compliance support — handled in-house by the same engineers who design the products.
Electronics Design & PCB Layout
Multi-layer PCB layout, schematic capture, signal integrity analysis, and high-speed design — from concept through fabrication-ready Gerbers.
Embedded Software Development
Firmware for microcontrollers and processors, RTOS integration, device drivers, and safety-critical software developed to IEC 62304.
Medical Device Development
End-to-end medical device development including design controls, risk management, FDA-compliant software, and 510(k) submission support.
Switching Power Supply Design
AC/DC and DC/DC converter design with a focus on efficiency, thermal management, and EMI compliance. Extensive experience with isolated and non-isolated topologies.
EMI/EMC Compliance
Pre-compliance testing, board redesigns to meet CISPR and FCC requirements, and support through radiated emissions and susceptibility certification testing.
510(k) & Regulatory Compliance
Regulatory strategy, design history files, risk analysis, and preparation of FDA 510(k) submissions for Class II medical devices.
Trusted by leading companies
About SiGenix
Engineers who’ve done it before
SiGenix was founded by engineers who developed their skills in global medical, transportation, and defense industries. For over 20 years, we’ve delivered state-of-the-art hardware and software solutions for clients ranging from Fortune 500 companies to early-stage startups.
We work as a standalone development partner or as an integrated extension of your team — bringing specialized knowledge in regulated industries where precision and compliance are not optional.
Work With UsIntellectual Property
14 U.S. Patents
Our president is a named inventor on patents spanning medical device monitoring, therapeutic compression, and patient compliance systems.
Automatic Rise Time Adjustment for Bi-Level Pressure Support System
Method for Managing Medical Information and Medical Information Management System
Pressure Support Compliance Monitoring System
Method and Apparatus for Monitoring and Controlling a Medical Device
Method and System for Tracking and Monitoring Patient Compliance with Medical Device Usage
Compression Therapy Device with Multiple Simultaneously Active Chambers
Methods and Systems for Determining Use Compliance of a Compression Therapy Device
Methods for Determining the Size of Body Parts as Part of Compression Therapy Procedures
Methods and Systems for Auto-Calibration of a Pneumatic Compression Device
Compression Therapy Device and Compression Therapy Protocols
Sleep Apnea Bi-Level Positive Airway Pressure Machine with Advanced Diagnostics and Self-Cleaning Capabilities
Methods and Systems for Determining Use Compliance of a Compression Therapy Device
Method and System for Monitoring Hand Hygiene Compliance
Compression Therapy Device and Compression Therapy Protocols
Ready to start your project?
Tell us what you’re building. We’ll tell you exactly how we can help.
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