Core Capabilities

MedTech engineering, embedded systems, regulated software, and production transfer. Full lifecycle support for federal R&D, medical device programs, and regulated industries.

1. Medical Device & Biomedical Engineering

Devices • Instrumentation • Design Controls • V&V

Medical and biomedical device development from concept through verification: electronics, sensors, firmware, system architecture, and FDA-aligned design controls and documentation.

  • Medical device system architecture and requirements
  • Biomedical signal acquisition and conditioning
  • Safety-critical design and risk management
  • Design history files and traceability
  • Verification and validation protocols
  • Regulatory pathway support (e.g., 510(k))

Representative tools: PCB design, analog front-end, signal processing, design controls

Government / regulated use: Federal biomedical R&D, medical device programs, SBIR/STTR medical technology, clinical research systems

2. Embedded Systems & Electronics

Electronics • Firmware • Sensors • Data Acquisition

Custom electronics design, embedded firmware, and sensor system engineering for medical devices, research instruments, and industrial applications.

  • Electronics design and PCB layout
  • Embedded firmware (C/C++, RTOS)
  • Sensor integration and signal conditioning
  • Power management and thermal design
  • Data acquisition and real-time processing
  • Hardware validation and test fixtures

Representative tools: PCB design, ARM/Cortex, RTOS, analog front-end, signal processing, EMC/EMI

Government / regulated use: Research instrumentation, medical device electronics, secure embedded platforms, data acquisition systems

3. Regulated Software & Secure Backend Platforms

Backend • APIs • Data Platforms • Clinical/Research Software

Secure backend systems, APIs, data platforms, and clinical or research software with traceability and development documentation practices designed to support regulatory and audit requirements. Device connectivity, real-time processing, and secure system architecture.

  • Secure backend and API development
  • Data platforms and storage architecture
  • Clinical and research software applications
  • Device connectivity and data ingestion
  • Real-time processing and streaming pipelines
  • Scientific computing and analysis infrastructure

Representative tools: .NET, cloud services, REST/API, databases, secure architecture

Government / regulated use: Federal data systems, medical device software (SiMD/SaMD), research data platforms, secure backend for regulated environments

4. Research Instrumentation & Scientific Systems

Biomedical • Lab • Data Collection • Feasibility

Technology feasibility, proof-of-concept, and research-grade instrumentation for biomedical and scientific programs. Algorithm development, data collection platforms, and technology transfer documentation.

  • Technology feasibility and proof-of-concept
  • Research-grade instrumentation and data acquisition
  • Algorithm development and validation
  • Laboratory and scientific data platforms
  • Prototype iteration and refinement
  • Technology transfer documentation

Representative tools: MATLAB, Python, signal analysis, prototyping, feasibility studies

Government / regulated use: Federal R&D, NIH/NSF-style instrumentation, biomedical research systems, SBIR/STTR Phase I/II technical execution

5. Prototype, Manufacturing, and Production Transfer

DFM • Production • QA • Supplier Coordination

Manufacturing engineering from design-for-manufacturing through production transfer and quality system implementation. Continuity from development through production handoff.

  • Design for manufacturing (DFM/DFA)
  • Production test strategy and fixtures
  • Manufacturing process documentation
  • Supplier qualification and coordination
  • Production handoff package preparation
  • Quality system implementation support

Representative tools: DFM, production testing, SPC, supplier management, QMS

Government / regulated use: SBIR/STTR transition to production, federal manufacturing support, regulated product commercialization

For capability questions or to discuss program requirements.

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