Our Services

• Medical Device Engineering & Regulatory

  • Class II system design and documentation

  • Design Controls (21 CFR 820), ISO 13485 alignment

  • Risk management per ISO 14971

  • Verification & Validation strategy, execution, and reporting

  • Protocol creation, test automation, and traceability mapping

  • F. DHF/DMR remediation and audit preparation

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• Electronics Design & Analysis

  • Analog front-end design for biopotential systems (EEG, ECG, ERP)

  • Low-noise circuit design and impedance-matching networks

  • Power electronics for low-voltage and mains-level systems

  • Signal integrity analysis, CMRR optimization, noise modeling

  • PCB design (Eagle, Fusion 360), DFM review (RigidFlex and Stretchable Circuit experience)

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• Embedded Systems & Firmware

  • Microcontroller system architecture and peripheral integration

  • UART, SPI, I²C, BLE, USB interface debugging and optimization

  • Low-power embedded design

  • Sensor integration and calibration workflows

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• Test Engineering & Automation

  • Automated test development (LabVIEW, Python)

  • Hardware-in-the-loop systems

  • Calibration fixture development

  • Reliability and environmental testing design

  • Statistical data analysis of test results

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• Systems Engineering

  • Requirements development and refinement

  • Traceability and configuration management

  • Root-cause analysis and corrective actions

  • Cross-disciplinary integration (mechanical, electrical, firmware)

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• Product Development Consulting

  • Concept feasibility evaluation

  • Rapid prototyping and experimental design

  • Cost-down and manufacturability consulting

  • Supplier discovery and technical vetting

  • Lifecycle planning from prototype to production

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• R&D and Innovation Services

  • Early-stage research design

  • Custom instrumentation for physiology and bio-signals

  • Exploratory algorithm development for signal processing

  • Documentation for IP filings and technical disclosures

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• Documentation & Lifecycle Management

  • Full DHF (Design History File) ownership and structuring

  • DMR (Device Master Record) creation and production transition

  • Requirements management, trace matrices, and configuration control

  • Change-control workflows: engineering change orders, deviations, CAPA inputs

  • SOP development, work instructions, and controlled document authoring

  • Lifecycle planning from concept through sustaining engineering