Medical Device Software Testing Services | Class I, II, III Verification and Validation

images (3)-1-1 — Ensure ISO 13485–aligned Verification & Validation for safer and compliant medical devices.

Request a Compliance Consultation

Accelerate compliance. Reduce risk. Improve patient safety.

Coforge Digital Assurance delivers end-to-end medical device testing services that align with ISO 13485:2016, FDA 21 CFR Part 820, and global regulatory expectations. From verification & validation (V&V) and risk-based testing to CSV and IoT medical device QA, we help MedTech organizations confidently launch compliant, reliable, and secure devices.

Proven impact

+30% increase in release capacity

85% reduction in deployment costs

50% improvement in automation coverage for connected/IoT devices

+30% increase in release capacity

85% reduction in deployment costs

50% improvement in automation coverage for connected/IoT devices

IoT/Smart Medical Device QA

We test connected medical devices and smart healthcare systems (e.g., intelligent beds, sterilization equipment, home-care kits) for:

Connectivity, safety, and resilience under real-world conditions

Automation at scale for firmware, apps, and cloud components

Interoperability across device ecosystems and third-party integrations

Security & privacy controls appropriate for regulated environments

Connectivity, safety, and resilience under real-world conditions

Automation at scale for firmware, apps, and cloud components

Interoperability across device ecosystems and third-party integrations

Security & privacy controls appropriate for regulated environments

Result: Up to 50% improvement in automation coverage and faster, safer releases for connected devices.

Why Medical Device Testing Matters

Modern medical devices are increasingly software driven, connected, and regulated. Ensuring the safety, effectiveness, and performance of these devices requires regulatory aligned verification and validation, structured documentation (IQ/OQ/PQ), and a risk-based approach that prioritizes patient safety and audit readiness. Our services are designed to ensure your devices meet intended use, perform reliably under real world conditions, and are submission ready for FDA/CE.

Our Expertise in Medical Device Verification & Validation

We support Class I, II, and III devices across Diagnostics, Imaging, Orthopedics,
Surgical, Cardiology, and Dental specialties with a comprehensive service portfolio:

Medical device verification (requirements, design, implementation)
Medical device validation (intended use, clinical context, user workflows)
Risk-based testing using FMECA to identify critical failure modes early
Hardware-software integration testing for system reliability and safety
Interoperability testing across device interfaces and data flows
Software lifecycle testing aligned to your SDLC and quality system
Analytical instrument validation and method/system suitability checks
User acceptance testing (UAT) with clinical/user personas

Medical Devices Testing Center of Excellence

Coforge’s Medical Device Testing CoE brings domain-rich expertise, tooling accelerators, and reusable validation assets to compress timelines and ensure consistency:

Testing strategy designed for regulatory bodies and public safety expectations

Risk-based testing aligned to FMECA and device criticality

In-house training & certification programs for Healthcare & Life Sciences

Coverage-driven approach that targets the most defect-prone areas

Lifecycle V&V assets including IQ/OQ/PQ templates, RTMs, and SOPs

Metrics & quality dashboards for audit-ready reporting

Benefits Delivered to Global Healthcare Clients

Regulatory submission readiness with complete IQ/OQ/PQ and traceability

Accelerated release cycles and time-to-market

Reduced risk via FMECA-driven validation

Improved quality & reliability across devices and software

Cost optimization through automation and reusable validation assets

Actionable reporting for audits and continuous improvement

Representative Use Cases

Imaging & Diagnostics

Verification of acquisition, processing, and UI; performance validation under varied workloads; compliance documentation for FDA 510(k).

Orthopedic Implants

Firmware-app integration testing; risk-based validation of telemetry; UAT with clinician workflows.

Surgical Devices & Instruments

Hardware-software integration; sterilization cycle validations; traceability from hazards to test evidence.

Cardiac Pacemakers & Wearables

Connectivity, safety, and reliability testing; battery & telemetry performance; validation artifacts for submission.

Dialysis & Lab Analyzers

Analytical method validation, system suitability, QC checks, and CSV for lab informatics.

Connected/IoT Devices

End-to-end interoperability, security, and upgrade validation across device–app–cloud.

Medical Device Testing Approach (Analysis to Maintenance)

Coforge follows a structured, SDLC-aligned 5-phase Medical Device Testing Approach designed to ensure regulatory compliance, device reliability, and patient safety. Our risk-based validation model enables comprehensive testing of hardware, software, and peripheral components, ensuring they meet intended use, regulatory expectations, and compliance requirements.

Identify medical devices in scope and regulatory compliance requirements
Finalize Test Methodology, Validation Approach, and Deliverables
Develop Validation Plan & Validation Master Plan
Document functional, non-functional, and safety requirements
Establish design qualification criteria
Conduct risk assessment & impact assessment (FMECA-aligned)
Define communication model
Create metrics framework for traceability and audit readiness

Finalize Validation Plan and SDLC-aligned validation strategy
Develop IQ/OQ/PQ protocols and validation documentation
Author test cases, test scripts, and data requirements · Build Requirement Traceability Matrix (RTM)
Develop/review SOPs aligned with ISO 13485
Collaborate with client teams to validate test data needs · Conduct validation training · Obtain client sign-off

Perform smoke testing in controlled test environments
Execute code and documentation reviews
Execute test cases and full Verification & Validation suite (IQ, OQ, PQ)
Log defects, conduct root-cause analysis, and execute retesting cycles
Prepare test execution summary reports · Obtain client sign-off for validation closure

Compile hardware and software Test Execution Summary Report
Prepare defect summary, metrics, and SLA achievement reports
Generate Go/No-Go system release dashboard
Document best practices and lessons learned
Confirm audit-ready documentation package for regulatory bodies

Apply structured Change Control Plan · Log and evaluate change requests
Perform risk and impact assessments for changes
Obtain approvals and implement changes
Re-validate affected components as per regulatory expectations
Update the Go/No-Go release dashboard for each system update

Regulatory & Compliance Frameworks

ISO 13485:2016 – Quality management for medical devices
FDA 21 CFR Part 820 – Quality System Regulation (QSR)
CSV (Computer System Validation) – GxP aligned validation of computerized systems
IQ/OQ/PQ – Installation, Operational, and Performance Qualification
Risk based testing – FMECA to prioritize patient safety

Outcome: Submission readiness (FDA/CE), compliant documentation, and audit ready traceability.

Office folder with inscription ISO - International Organization for Standardization - on Office Desktop with Office Supplies. Business Concept on Blurred Background. Toned Image.

Regulatory & Compliance Frameworks

Types of Medical Device Testing We Conduct

Lifecycle V&V (verification and validation)
GUI & Non-GUI Testing
Performance & Reliability Testing
Compliance Testing
Interoperability Testing
Behavior Testing
User Acceptance Testing (UAT)
Hardware / Software Integration Testing
Analytical Instrument Validation
System Suitability & Quality Control Checks

Computer System Validation (CSV) Capabilities

Our CSV model ensures regulated systems and tools used across R&D,manufacturing, labs, and post-market processes meet compliance requirements:

Validation approach aligned to development and SDLC

Risk-based validation for hardware, software, and peripheral devices

Authentication & data integrity controls aligned to regulatory expectations

Timely, traceable verification with external/internal stakeholder reporting

Comprehensive IQ/OQ/PQ documentation packs and RTMs

FAQs

Verification checks whether the device/software meets specified requirements; validation confirms it fulfills intended use in the clinical context.

IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) are validation stages that demonstrate correct installation, expected operation, and performance under real-world conditions.

Through SDLC aligned validation, risk-based testing (FMECA), complete IQ/OQ/PQ documentation, RTMs, SOPs, signoffs, and audit ready reports mapped to regulatory clauses.

Yes. We tailor validation depth and evidence to device classification, risk profile, and market submission pathway (e.g., 510(k), PMA, CE).

Yes. We cover connectivity, interoperability, automation at scale, security, and resilience across device–app–cloud components.

Timelines vary by device class, scope, and risk. Our accelerators and reusable validation assets compress cycle time while maintaining compliance.

Medical Device Testing & Validation Services

Ensure ISO 13485–aligned Verification & Validation for safer and compliant medical devices.

Accelerate compliance. Reduce risk. Improve patient safety.

Proven impact

+30% increase in release capacity

85% reduction in deployment costs

50% improvement in automation coverage for connected/IoT devices

+30% increase in release capacity

85% reduction in deployment costs

50% improvement in automation coverage for connected/IoT devices

IoT/Smart Medical Device QA

Connectivity, safety, and resilience under real-world conditions

Automation at scale for firmware, apps, and cloud components

Interoperability across device ecosystems and third-party integrations

Security & privacy controls appropriate for regulated environments

Connectivity, safety, and resilience under real-world conditions

Automation at scale for firmware, apps, and cloud components

Interoperability across device ecosystems and third-party integrations

Security & privacy controls appropriate for regulated environments

Awards & Recognitions

Coforge wins Med Tech Breakthrough Award 2025 for Clinical Trial Innovation with Espero Health

Why Medical Device Testing Matters

Our Expertise in Medical Device Verification & Validation

Certifications & Credentials

Medical Devices Testing Center of Excellence

Testing strategy designed for regulatory bodies and public safety expectations

Risk-based testing aligned to FMECA and device criticality

In-house training & certification programs for Healthcare & Life Sciences

Coverage-driven approach that targets the most defect-prone areas

Lifecycle V&V assets including IQ/OQ/PQ templates, RTMs, and SOPs

Metrics & quality dashboards for audit-ready reporting

Benefits Delivered to Global Healthcare Clients

Regulatory submission readiness with complete IQ/OQ/PQ and traceability

Accelerated release cycles and time-to-market

Reduced risk via FMECA-driven validation

Improved quality & reliability across devices and software

Cost optimization through automation and reusable validation assets

Actionable reporting for audits and continuous improvement

Representative Use Cases

Imaging & Diagnostics

Verification of acquisition, processing, and UI; performance validation under varied workloads; compliance documentation for FDA 510(k).

Orthopedic Implants

Firmware-app integration testing; risk-based validation of telemetry; UAT with clinician workflows.

Surgical Devices & Instruments

Hardware-software integration; sterilization cycle validations; traceability from hazards to test evidence.

Cardiac Pacemakers & Wearables

Connectivity, safety, and reliability testing; battery & telemetry performance; validation artifacts for submission.

Dialysis & Lab Analyzers

Analytical method validation, system suitability, QC checks, and CSV for lab informatics.

Connected/IoT Devices

End-to-end interoperability, security, and upgrade validation across device–app–cloud.

Medical Device Testing Approach (Analysis to Maintenance)

Regulatory & Compliance Frameworks

Regulatory & Compliance Frameworks

Computer System Validation (CSV) Capabilities

Validation approach aligned to development and SDLC

Risk-based validation for hardware, software, and peripheral devices

Authentication & data integrity controls aligned to regulatory expectations

Timely, traceable verification with external/internal stakeholder reporting

Comprehensive IQ/OQ/PQ documentation packs and RTMs

FAQs

1) What’s the difference between verification and validation for medical devices?

2) What are IQ, OQ, and PQ?

3) How do you support ISO 13485 and FDA 21 CFR Part 820 compliance?

4) Do you handle Class I, II, and III devices?

5) Do you test connected/IoT medical devices?

6) How long does a validation cycle take?

Let’s Strengthen the Safety & Reliability of Your Medical Devices

Join our winning team.