Medical Device Validation and Verification

Mitigating risks continually 

Safety, efficiency, reliability, usability, security, and regulatory compliance are key considerations in engineering medical devices and healthcare software. Our medical device validation and verification services blend deep medical device expertise with proven testing practices to deliver high-quality, safety-driven solutions for devices and software. We assure quality at every step - from medical devices and device interfacing software to APIs, cloud platforms, and mobile apps.

Independent Verification of Device Software and Cloud Apps

We provide comprehensive independent verification services for device interface software and cloud-based healthcare applications, including end-to-end healthcare application testing.

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 medical device software testing and healthcare app testing services, including API, web, desktop, and mobile applications
  • 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 testing of medical devices and software to support safe and effective use. 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. 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 

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.