Engineering Services for Medical Devices, Embedded Systems & Power Electronics

Our engineers handle the full electronics design cycle — schematic capture, component selection, multi-layer PCB layout, design rule checks, and manufacturing support. We have deep experience with mixed-signal designs, high-speed digital interfaces, and RF front-ends.

• Schematic capture and net list generation
• Multi-layer PCB layout (2 to 16+ layers)
• High-speed signal integrity analysis
• Impedance-controlled trace routing
• Thermal management and power plane design
• Gerber and fabrication documentation
• Design for manufacturability (DFM) review

We develop firmware and embedded software for microcontrollers, DSPs, and application processors across a wide range of architectures. We have deep hands-on experience with STM32 (STM32L4, STM32H7, STM32F series) and Infineon PSoC devices, including battery-powered applications where minimizing current consumption is as important as the application logic itself. For medical and safety-critical applications, all software is developed under a quality management system aligned to IEC 62304.

• STM32 and Infineon PSoC firmware development
• Ultra-low-power design: sleep modes, dynamic clock scaling, peripheral gating
• Battery life optimization and current profiling
• Bare-metal and RTOS-based firmware (FreeRTOS, ThreadX)
• Device drivers and BSP development
• Communication protocols (CAN, UART, SPI, I2C, USB, BLE)
• Safety-critical software per IEC 62304
• Software architecture, unit testing, and code review
• Bootloaders and over-the-air update systems

We assemble and bring up prototype boards in-house, from low-volume SMT work to manual fine-pitch soldering. Having the design team handle assembly ensures fast debug cycles and eliminates the communication gap between design and hardware.

• SMT and through-hole prototype assembly
• Fine-pitch BGA and QFN rework
• First-article hardware bring-up and debug
• Oscilloscope, logic analyzer, and JTAG debug
• Power supply sequencing and current profiling
• Thermal imaging and stress testing

Power supply design is one of our deepest areas of expertise. We design AC/DC and DC/DC converters optimized for efficiency, thermal performance, and electromagnetic compatibility. We select and design custom magnetics when off-the-shelf components won't meet specifications.

• AC/DC flyback, forward, and LLC resonant converters
• DC/DC buck, boost, buck-boost, and SEPIC topologies
• Synchronous rectification and multi-phase designs
• Custom transformer and inductor design
• Efficiency optimization and thermal analysis
• Pre-compliance EMI filtering and layout
• IEC 60601-1 isolation and safety requirements

Medical device development requires more than good engineering — it requires a disciplined quality process. SiGenix has extensive experience developing hardware and software under FDA design controls, with deep familiarity with the documentation, risk analysis, and testing required for cleared devices.

• Design history file (DHF) development and maintenance
• Risk management per ISO 14971
• IEC 62304 software lifecycle documentation
• IEC 60601-1 hardware safety requirements
• Usability engineering (IEC 62366)
• Verification and validation (V&V) protocol development
• Pre-submission meeting support and FDA correspondence

EMI failures are expensive and demoralizing late in a product cycle. We design for compliance from the start — using proper layout techniques, filtering strategies, and pre-compliance testing to predict and fix issues before the formal test. When products do fail, we diagnose root causes and implement targeted fixes.

• EMI-aware PCB layout and partitioning
• Common-mode and differential-mode filter design
• Pre-compliance radiated and conducted emissions testing
• IEC 61000-4-x susceptibility and immunity testing
• CISPR 11/22 and FCC Part 15 compliance
• Medical device EMC per IEC 60601-1-2
• Post-failure root cause analysis and redesign

Bringing a medical device to market in the US requires a structured regulatory strategy. SiGenix supports clients from initial device classification through 510(k) submission — writing the technical documentation, coordinating testing, and responding to FDA questions.

• Device classification and predicate device strategy
• 510(k) substantial equivalence argument development
• Technical file and design documentation assembly
• Performance testing and bench test protocol development
• Biocompatibility and sterilization evaluation support
• FDA pre-submission (Q-sub) meeting preparation
• Response to FDA additional information (AI) requests