Medical Device Validation and Verification

Ensuring Safe, Reliable, and Regulatory-Ready Healthcare Technologies  

Delivering confidence in every medical device and digital health solution. Our Verification & Validation (V&V) services combine deep MedTech expertise with rigorous testing and quality assurance to help healthcare innovators deliver safe, reliable, secure, and regulatory-ready products.

From medical devices and device software to APIs, cloud platforms, and mobile applications, we ensure quality at every stage. As an extension of your team, iORBIT's V&V specialists support the entire product lifecycle, covering software, usability, hardware, firmware, and system-level testing

SaMD & Software V&V

We help healthcare innovators validate and verify Software as a Medical Device (SaMD), device interfacing software, and cloud-based healthcare applications, ensuring quality, security, reliability, and regulatory readiness throughout the development lifecycle. Combining deep medical device software testing expertise with automated validation and test frameworks, we support global software validation, regulatory compliance, and SaMD verification requirements.

Key Capabilities:

  • End to end software testing, SaMD validation, and medical device software verification aligned with IEC 62304 software lifecycle requirements.
  • Evaluation of software quality attributes aligned with ISO 25010 software quality model, including functionality, performance testing, reliability, security testing, compatibility, and interoperability. 
  • Verification of software risk controls, usability engineering, and hazard mitigation in accordance with ISO 14971 risk management and IEC 62366 usability engineering.
  • Cybersecurity testing, data privacy compliance, and vulnerability assessment aligned with HIPAA compliance, GDPR compliance, and IEC 81001-5-1 cybersecurity standard.
  • Automated testing, test automation frameworks, and regression testing for APIs, web applications, mobile apps, desktop software, and cloud based healthcare platforms.
  • Integration testing for EHR integration, EMR systems, HMS platforms, ERP systems, and connected healthcare interoperability ecosystems.
  • Support for Design History File (DHF), software validation documentation, traceability matrix, verification reports, and FDA software validation compliance for regulatory submissions. 

Human Factors & Usability Validation

We provide independent human factors and usability validation for medical devices and healthcare software to ensure safe, effective, and intuitive use in real clinical environments. Our approach is aligned with IEC 62366-1 usability engineering, ensuring use related risks are systematically identified, evaluated, and mitigated throughout the product lifecycle.

  • Independent analysis of user workflows, task structures, and use related risks across medical devices and software systems aligned with IEC 62366-1. 
  • Identification of critical use scenarios and development of targeted test cases for usability risk mitigation and safety validation.  
  • Formative usability evaluations through expert UI reviews, heuristic assessments, and early stage functional usability testing. 
  • Summative human factors validation through structured usability studies in real world clinical environments and connected healthcare ecosystems. 

Medical Device Hardware, Firmware & System-Level Testing

We provide end-to-end independent testing services for medical devices, covering hardware, firmware, software, and system-level validation. Our medical device validation services ensure compliance, safety, and operational reliability.

  • Hardware unit testing right from board bring up tests 
  • Firmware unit testing, HW/FW integration testing 
  • Device integration testing with device control software,EHR and cloud interfaces 
  • Early review of device user interface to identify use related risks and ease of use features 
  • Testing for device functionality, performance parameters, reliability, operations use variation and safety 
  • Use related risk analysis and providing mitigation feedback 
  • Partnering with test labs for compliance testing like electrical safety, EMI/EMC testing, biocompatibility testing, coexistence testing, functional parameters compliance testing 

Automated Verification & Validation (V&V)

Our automation-first Verification & Validation (V&V) approach helps MedTech companies accelerate product development, improve quality, and achieve regulatory compliance with confidence. We design and implement automated test frameworks that significantly reduce testing cycle times, minimize manual effort, and provide comprehensive traceability throughout the product lifecycle.

Leveraging advanced automation technologies such as LabVIEW, NI DAQ-based test systems, and embedded communication protocol automation (UART, I2C, SPI, CAN, BLE, and more), we enable rapid and repeatable verification across hardware, software, and system-level requirements.

  • Automated Design Verification & Validation for medical devices and SaMD  
  • LabVIEW and NI DAQ-based automated test system development.  
  • Embedded protocol testing and automation (UART, I2C, SPI, CAN, BLE, USB, Ethernet. 
  • Hardware-in-the-loop (HIL) and system-level integration testing. 
  • Automated regression, functional, performance, and reliability testing. 
  • Test framework development for connected and cloud-enabled medical devices.
  • Requirements-based verification with end-to-end traceability. 
  • Automated generation of test reports and audit-ready documentation. 
  • Validation support aligned with IEC 62304, ISO 13485, FDA, MDR, and other applicable standards. 

Independent Verification of Device Software and Cloud Apps

We provide comprehensive independent verification services for device interface software and cloud-based healthcare applications.

Key Capabilities:

  • Testing the end to end functionality of the software and integration workflows 
  • Coverage of software quality characteristics aligned to ISO25010 quality model  – Functionality suitability, Performance during load and stress, Security, compatibility, Flexibility, safety, Interoperability 
  • Focus on use related risks, reliability, performance parameters, security and HIPAA compliance 
  • Automated testing solutions supporting quick turnaround for testing the API, Web applications, desktop applications and mobile apps 
  • Testing for third party interfaces like EHR, HMS, ERP and device management systems 
  • Support for Design history file creation with documentation related to formal verification procedures, formal verification reports, evidences, traceability matrix and, issues /anomalies documentation and tracking 

Usability Risk Testing for Devices and Software

We offer independent usability risk assessments to support safe and effective use of medical devices and software. Our approach includes task analysis and identification of use-related risks, leading to targeted test scenarios for risk mitigation.

  • Independence analysis of user tasks and use related risks for a medical device and software 
  • Identification of test scenarios for risks mitigation testing 
  • Formative evaluation through user interface reviews and early functional testing 
  • Summative evaluation or human factors validation testing through a connected eco-system of hospitals 

Independent Testing of Medical Devices

We provide end-to-end independent testing services for medical devices, covering hardware, firmware, software, and system-level validation.

  • Hardware unit testing right from board bring up tests 
  • Firmware unit testing, HW/FW integration testing 
  • Device integration testing with device control software,EHR and cloud interfaces 
  • Early review of device user interface to identify use related risks and ease of use features 
  • Testing for device functionality, performance parameters, reliability, operations use variation and safety 
  • Use related risk analysis and providing mitigation feedback 
  • Partnering with test labs for compliance testing like electrical safety, EMI/EMC testing, biocompatibility testing, coexistence testing, functional parameters compliance testing 

Insights & Innovations

Our Success Stories

The iOrbit Edge

Standards-Compliant V&V Processes

Aligned with ISO 13485/IEC 62304, offering V&V toolkits and automation for fast, thorough testing.

Human Factors Engineering (HFE) Validation

FDA/IEC 62366-aligned processes with templates and structured HF validation, verification, and documentation to support safe and effective medical device validation.

Robust testing and compliance ecosystem.

In-house testing frameworks, automation tools, and partner network for fast, compliant validation and safety.