PRODUCT ENGINEERING

We guide MedTech innovation by designing groundbreaking medical devices that shape healthcare’s future. Collaborating closely with partners, we create products that improve patient outcomes and build a better world. Our integrated solutions take your concept from idea to impact, offering end-to-end development to turn vision into reality.

Hardware Engineering & Design Services

We offer end-to-end hardware design services for advanced medical devices, delivering high-performance, reliable, and customized solutions.

Key Capabilities:

  • System design including electromechanical subsystems
  • Complex circuit design with multilayer PCB schematics and assemblies
  • High-performance, reliable hardware engineering
  • Full FPGA/ASIC support for custom processing
  • Processor selection and data flow optimization
  • Complete hardware solutions with maximum efficiency and precision

Software Product Engineering

We offer end-to-end software product engineering services tailored to the unique needs of the healthcare industry.

Key Capabilities:

  • Full-Cycle Software Development – From ideation to deployment across cloud, mobile, and embedded platforms.
  • Medical-Grade Compliance & Security – Aligned with FDA, CE, IEC 62304, HIPAA, and GDPR standards.
  • AI & Data-Driven Solutions – AI/ML for diagnostics, decision support, and patient engagement.
  • Connected Health & IoMT Integration – Device and wearable integration using HL7, FHIR, DICOM, and custom protocols.
  • Cloud & Remote Care Platforms – Scalable solutions for RPM, telemedicine, and virtual care.
  • EHR/HIS Interoperability – Smooth integration with hospital systems and health networks.

Cloud Application Development, Deployment & Monitoring Services

We offer end-to-end cloud engineering services to support healthcare organizations across their product and business lifecycle. Our solutions enable secure, scalable, and interoperable digital health systems.

Key Capabilities:

  • Cloud-Based Application Development
    Design and development of scalable, secure applications for healthcare.
  • System & Platform Integration
    Seamless integration with existing systems and third-party platforms.
  • Modern Cloud Architecture
    Microservices, DevSecOps, and edge computing for agility and performance.
  • Cloud Infrastructure Management
    Managing & Optimizing cloud  infrastructure management that ensure high availability with minimum investment
  • IoMT Cloud Platform
    Scalable, multi-tenant secure platform with edge computing and flexible deployment to meet regulatory and performance needs.

Verification & Testing Services

We offer end-to-end Verification & Testing services tailored specifically for medical technology products. Our approach ensures that devices meet stringent quality, safety, and regulatory requirements across global markets.

Our services include:

  • Functional Testing: Validating all features and workflows to ensure they meet design specifications.
  • Performance Testing: Assessing system stability, accuracy, and responsiveness under varied operating conditions.
  • User Acceptance Testing (UAT): Engaging real users and clinicians to validate usability and clinical relevance in real-world scenarios.
  • Cybersecurity Testing: Identifying vulnerabilities and ensuring protection against potential threats in compliance with industry standards like FDA, MDR, and ISO/IEC 80001.

Hardware Engineering & Design Services

We offer end-to-end hardware design services for advanced medical devices, delivering high-performance, reliable, and customized solutions.

Key Capabilities:

  • System design including electromechanical subsystems
  • Complex circuit design with multilayer PCB schematics and assemblies
  • High-performance, reliable hardware engineering
  • Full FPGA/ASIC support for custom processing
  • Processor selection and data flow optimization
  • Complete hardware solutions with maximum efficiency and precision

Software Product Engineering

We offer end-to-end software product engineering services tailored to the unique needs of the healthcare industry.

Key Capabilities:

  • Full-Cycle Software Development – From ideation to deployment across cloud, mobile, and embedded platforms.
  • Medical-Grade Compliance & Security – Aligned with FDA, CE, IEC 62304, HIPAA, and GDPR standards.
  • AI & Data-Driven Solutions – AI/ML for diagnostics, decision support, and patient engagement.
  • Connected Health & IoMT Integration – Device and wearable integration using HL7, FHIR, DICOM, and custom protocols.
  • Cloud & Remote Care Platforms – Scalable solutions for RPM, telemedicine, and virtual care.
  • EHR/HIS Interoperability – Smooth integration with hospital systems and health networks.

Cloud Application Development, Deployment & Monitoring Services

We offer end-to-end cloud engineering services to support healthcare organizations across their product and business lifecycle. Our solutions enable secure, scalable, and interoperable digital health systems.

Key Capabilities:

  • Cloud-Based Application Development
    Design and development of scalable, secure applications for healthcare.
  • System & Platform Integration
    Seamless integration with existing systems and third-party platforms.
  • Modern Cloud Architecture
    Microservices, DevSecOps, and edge computing for agility and performance.
  • Cloud Infrastructure Management
    Managing & Optimizing cloud  infrastructure management that ensure high availability with minimum investment
  • IoMT Cloud Platform
    Scalable, multi-tenant secure platform with edge computing and flexible deployment to meet regulatory and performance needs.

Verification & Testing Services

We offer end-to-end Verification & Testing services tailored specifically for medical technology products. Our approach ensures that devices meet stringent quality, safety, and regulatory requirements across global markets.

Our services include:

  • Functional Testing: Validating all features and workflows to ensure they meet design specifications.
  • Performance Testing: Assessing system stability, accuracy, and responsiveness under varied operating conditions.
  • User Acceptance Testing (UAT): Engaging real users and clinicians to validate usability and clinical relevance in real-world scenarios.
  • Cybersecurity Testing: Identifying vulnerabilities and ensuring protection against potential threats in compliance with industry standards like FDA, MDR, and ISO/IEC 80001.

The iOrbit Edge