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Verification and Validation

Services for Medical Devices

Medical

Breadcrumb

  1. Services
  2. Product Testing and Validation
  3. Engineering Reliability Across Medical Devices

Engineering Reliability Across Medical Devices

We understand that patient safety and regulatory compliance are non-negotiable. Our medical devices testing practice is designed to help you bring innovative solutions to market with confidence. From early-stage functional testing to final compliance validation, we ensure your products meet the highest safety and performance standards.

With our expertise, you can focus on revolutionizing healthcare while we handle the testing that makes your breakthroughs reliable and safe.

Medical

Service Offerings

Functional Testing

  • Unit, Integration, and System Testing
  • Smoke, Sanity, and Regression Validation
  • Manual and AI/ML-Driven Automation Testing

Compliance Testing

  • FDA (21 CFR Part 11) Compliance Reviews
  • ISO 13485, ISO 14971, MDR Classes I to III Testing
  • IEC Standards, Including 60601 (4th ed.) and 62304

Non-Functional Testing

  • Performance Testing (Load, Volume, Endurance, and Scalability)
  • Security and Cybersecurity Validation
  • UI/UX Evaluation for Maximized Usability

Hardware and Embedded Systems

  • Hardware-in-the-Loop (HIL) Testing
  • Optical, Acoustic, and RF Test Development
  • Firmware and Embedded Hardware Validation

Custom Test Fixture Design

  • Bed of Nails Test Fixtures
  • Custom EOL Testing Solutions
  • RF Shielded Chambers and Environmental Stress Test Setups

HIL Testing & CI/CD Integration

  • Automated Test Development with GenAI
  • Remote-Enabled Solutions for Anytime, Anywhere Testing
  • Intelligent Risk Categorization Using Device and Test Logs

Full-Service Test Ecosystem

•Cloud, Web, and Mobile Testing for Applications

•SaMD (Software as a Medical Device) End-to-End Testing

•DHF Automation for Validation Documentation

We Add Value to Your Innovation Process

  • Regulatory Compliance Made Simple: Proven compliance with FDA guidelines, ISO 13485, IEC 62304, and more. From Class I to III devices and software classifications (A, B, and C), we enable unmatched first-time approval readiness.
  • Advanced Testing Capabilities: Cutting-edge frameworks like GenAI-driven test development, automated document generation for DHF, and sophisticated HIL validation techniques.
  • Tailor-Made Solutions: Custom test fixture development to software and hardware co-validation, changing the way MedTech pioneers approach quality assurance.
  • Global Facilities and Scalability: With customer-specific test centers, in-house EMI/EMC labs, and 24/7 testing support, we provide a seamless experience regardless of scope or urgency.
  • Team Excellence: With 500+ test automation engineers and 250+ ISTQB-certified specialists, you benefit from unmatched technical expertise and domain knowledge.
medical

Our solution accelerators

LTTS EvQUAL

EvQUAL is an intelligent, in-house test automation platform that delivers unmatched market success and customer delight across industries, including, consumer electronics, industrial products, telecom, media and entertainment, automotive, and medical devices. The tool can drive multiplatform and multidevice automation to ensure a faster time to market and enhanced quality for video and broadband devices, OTT apps across media platforms, web/mobile/desktop apps, handhelds/wearables, IVI systems, and industrial/medical devices.

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LTTS MicroHIL

MicroHIL is an optimized, flexible, cost-effective, and easily deployable platform for signal generation and data acquisition in HIL testing processes. The solution can verify and validate multiple industrial, automotive, and medical products. It accelerates the development level testing and assembly stage testing and helps users avoid a large outlay on full blown HIL systems.

LTTS EmbedVIO

EmbedVIO is a CI-CD enabled and cloud-ready solution that seamlessly virtualizes hardware and provides a platform for execution of actual source on any host environment. The proprietary simulation binder (for all the hardware components) complies actual code to generate simulation build and provides an interface that can be easily plugged into a visualization package for delivering an interactive experience similar to real-world environments.

LTTS Nouvis

Nouvis from LTTS is a robust, efficient and scalable tool that leverages AI/ML algorithms for advanced data management and analytics to connect the complete system, applications, dependencies, and processes into a single unified platform.

AI-test

AI-Test is a plug-n-play AI-driven module that leverages natural language generation and associated techniques to generate Python/Robot/JS test scripts from test cases provided in English or any of the other 40 supported natural languages. The input can be in unstructured or grammatically incorrect formats as well. The solution’s auto-script module is capable for self-healing of generated scripts against changes in the app UI.

Why partner with us?

Seamless FDA and ISO Compliance: From EMC Testing to risk management in ISO 14971, we simplify complex compliance processes.

Patient-Centric Safety: Our early defect detection frameworks ensure your device outperforms expectations, protecting patients and your reputation.

Faster Time-to-Market: We reduce test cycles by up to 30% through automation and parallel testing, enabling quicker approvals.

Cost Efficiency: Avoid unexpected expenses with smart testing approaches, early risk identification, and tailored solutions.

Innovation Enablement: Equipped with AI/ML frameworks and tools, we support your innovations with future-ready validation methods, enabling smarter devices for better healthcare outcomes.

medical

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