Medical Device

End-to-end medical device software stack capabilities: from operator-facing UI design to precision instrument control, we engineer software for complex diagnostic devices, integrating sensors, robotics, and real-time systems to ensure accuracy, reliability, and scalability.

• Instrument User Interfaces & Workflows: End-to-end UI design and engineering for clinical analyzer operators, optimized for regulated environments.  
• Instrument Control Software: Precision control of robotic arms, fluidic pumps, sensors, and electromechanical systems for complex diagnostic platforms
• Calibration & QC Software: Calibration and quality control software used internally by the manufacturers to ensure analytical accuracy and regulatory traceability, aligned with 21 CFR 820.70 (production software validation) rather than medical device regulation.
• Device Cybersecurity per FDA & EU Guidelines: Threat modeling, penetration testing, and secure-by-design architectures aligned with FDA Cybersecurity Guidance (2023) and EU MDR/IVDR cybersecurity requirements. 

We build the control, analysis, and reporting software behind diagnostic instrument platforms. From assay logic and data pipelines to advanced algorithms, we help power molecular and genomic testing — transforming raw data into accurate, validated diagnostic results.

• Molecular (qPCR) Analyzers: High-throughput, fully automated software for molecular diagnostic analyzers.
• Sequencing (NGS) Instruments: Run control, data pipelines, and variant reporting for next-generation sequencing platforms.
• Immunoassay & Chemistry Analyzers: Software for immunoassay and clinical chemistry analyzer platforms.
• Point-of-Care Analyzers: Analyzer software designed for decentralized clinical settings.
• Digital Pathology Solutions: End-to-end software for digital pathology platforms, including image management, annotation, AI-assisted analysis, and workflow integration.
• Companion Diagnostics & Software as a Medical Device (SaMD): Regulated diagnostic software that interprets results and supports clinical decision-making — from companion diagnostics to AI-driven decision support tools. 

Fix fragmented lab operations by connecting systems, data, and workflows — reducing handoffs and enabling faster, more predictable throughput across the lab.  We connect instruments, systems, and data into a unified lab environment. Our engineers build bi-directional interfaces to laboratory information systems (LIS/LIMS), along with IoT and mobile connectivity solutions that keep instrument, cloud, and enterprise systems in sync.

• LIS/LIMS Integration: Bi-directional interface software compatible with HL7, FHIR, and ASTM protocols. Instrument- and LIS-agnostic, with real-time error detection and recovery.
• Data Format Conversion:  Middleware that converts instrument flat-file outputs (CSV, TXT, XML) into standard HL7 or ASTM formats for downstream systems.
• Cloud & IoT/IoMT Connectivity:  Cloud-based data models and Internet of Medical Things (IoMT) solutions that are scalable, secure, and regulatory compliant. Extend device data into secure, cloud-based IoMT platforms that enable real-time remote monitoring, scale with demand, and integrate across enterprise systems.
• Medical Device Data Systems (MDDS):  Software for collecting, storing, and transferring medical device data across the enterprise. 

A dedicated Data Analytics team helps us develop sophisticated methods for analyzing your data. We build the software that transforms raw instrument output into actionable results for clinicians and laboratory teams — from data acquisition and analysis to bioinformatics pipelines, patient reporting, and clinical decision-support applications.

• Data Acquisition & Analysis: Software that captures and processes raw instrument output for downstream analysis and interpretation.
• Bioinformatics Pipelines: Algorithm and pipeline development for genomic and molecular diagnostic data.
• Result Interpretation & Patient Reporting: Software that transforms analyzed data into clinician- and patient-facing reports.
• Clinical Decision-Support Applications: Applications that support clinical decision-making based on diagnostic results. 

Embed compliance, risk management, and cybersecurity into development. Before a line of code ships, we identify what can go wrong. Our engineers apply systems engineering and risk analysis to anticipate failure modes early — helping teams address issues proactively rather than reactively.

• Hazard & Risk Analysis: Design Failure Modes and Effects Analysis (dFMEA), Software Hazard Analysis (SHA), and cybersecurity risk analysis.
• Requirements & Systems Engineering: Product architecture and systems analysis, requirements engineering, and dependency analysis across software, hardware, and assay subsystems.
• Safety Controls & Error Handling: Software that manages error handling, retries, sample invalidation, and controls for false-positive and false-negative results.
• Cybersecurity & OS Hardening: Secure-by-design software aligned with FDA cybersecurity requirements, including threat modeling, vulnerability scanning, penetration testing, and OS hardening for connected instruments. 

Ensure products meet FDA, ISO, and global regulatory requirements. A result is only defensible if the verification evidence, design history, and quality systems behind it can withstand regulatory scrutiny. We build the quality processes, verification evidence, and regulatory submissions that demonstrate your software is safe, compliant, and ready for review — aligned with FDA, ISO, and IEC requirements at every stage.

• Quality Management & Compliance: Development processes aligned with FDA 21 CFR Part 11/820, ISO 13485, and IEC 62304, with complete design input and output documentation for IVD, RUO, and IUO devices.
• Software Verification & Validation: Verification planning and protocol execution; unit, white-box, and black-box testing; GMP process validation (IQ/OQ/PQ); and usability and human factors review.
• Design History File & Gap Remediation: DHF audits, gap analysis, and documentation remediation to close submission gaps before filing.
• Regulatory Submission Support: Preparation of 510(k), De Novo, PMA, EUA, and CE technical file submissions, along with response support for regulatory agency questions.