Pittsburgh, PA — Est. 2005

Engineering Excellence
in Electronics Design

SiGenix delivers expert electronics design, embedded software, medical device development, and regulatory compliance. From schematic to certified.

20+
Years of Experience
50+
Products Shipped
510(k)
Submissions Supported
Class II
Medical Devices

What We Do

Deep expertise across the full stack

From the first schematic to the regulatory filing, SiGenix covers every layer of electronics product development — from schematic to certified.

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

Bombardier
Philips
Bosch
ALung Technologies
Circadiance
Vixiar
Trice

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 Us
Medical & FDA
IEC 62304, 510(k), Design Controls
Power Electronics
AC/DC, DC/DC, High Efficiency
EMI/EMC
CISPR 11/22, FCC Part 15, IEC 61000
Embedded Systems
RTOS, Safety-Critical, Low Power

Ready to start your project?

Tell us what you’re building. We’ll tell you exactly how we can help.

Get in Touch