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    Accelerating Verification and Validation of Medical Devices with Future-Ready Solutions

    CyientAccelerating Verification and Validation of Medical Devices with Future-Ready Solutions
    Verification and Validation of Medical Devices

    Embedded Technologies are
    Reshaping the Healthcare Industry

    Smart devices are transforming the healthcare and life sciences industry. Increased connectivity between devices, consumers, and physicians is pushing OEMs to build innovative solutions that deliver high-quality, patient-centric care and improve access to advanced diagnostics for millions. Secure embedded systems are at the core of these machines. They warrant continuous upgrades of medical-grade embedded technologies to reduce size, increase processing power, and incorporate programmed automatic technologies to provide improved treatment and medication for patients.

    Challenges in Verification and Validation
    of Embedded Systems

    MedTech companies are challenged with increased costs for verification and validation of embedded systems and software due to increased compliance requirements, product complexity, and scarcity of resources.

    Scalling V&V Expertise

    • Availability of V&V expertise across development life cycle
    • Flexibility to quickly ramp up and down Continuous Upgrade

    Continuous Upgrade

    • Customer proprietary test platforms for each domain
    • Need for setting up separate test platforms

    In-House Automation

    • Lack of bandwidthfor in-house automation
    • High manual testing efforts and low Rol on automation

    Regulatory Compliance

    • Stringent regulatory compliance requirements
    • Varying requirements across geographies and governments

    Legacy V&V Tools

    • V&V for legacy products
    • Lack of cybersecurity
    • Adaptability to new technologies

    Product Complexity

    • Increased softwarization of products with frequent releases
    • Mobile technologies integrated with products

    Our Value Proposition

    With 20+ years of experience in medical devices, Cyient is a preferred product development partner for medical device and life science companies worldwide. We leverage our subject matter expertise in medical devices across various modalities to deliver high-quality and cost-competitive solutions.

    Orthopedics

    Orthopedics

    Consumer_Healthcare​

    Consumer Healthcare​ Pharmaceuticals​

    Pharmaceuticals

    Pharmaceuticals

    Cardiology_&_Patient_Monitoring​

    Cardiology & Patient Monitoring​

    Diagnostic_Imaging​_ndoscopy

    Diagnostic Imaging​

    Endoscopy

    Endoscopy

    In-Vitro_Diagnostics​

    In-Vitro Diagnostics​

    Ophthalmology

    Ophthalmology

    Respirator_Care​

    Respiratory Care​

    Ear-Nose-Throat​

    Ear, Nose, & Throat​

    Urology

    Urology

    Digital_Health​

    Digital Health​

    Our domain expertise in V&V across various classes of medical devices, coupled with our technology accelerators can enable customers achieve


    40%

    Faster time-to-market through reduced cycle time and increased automation

    20%

    Cost savings through Al-led solutions for testing,compliance and delivery

     

    Key pillars of our proposition

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    Embedded CoE/ V&V Factory

    1400+ engineers specialized in embedded V&V for setting up a dedicated V&V factory

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    noun_Processing_4022537

    Solution Accelerators

    Ready-to-use tools, framework, and infrastructure (CyFAST,CertBENCH, CertSAFE)

    noun_Processing_4022537
    noun_Processing_4022537

    Expertise in Regulatory Compliance

    ISO 13485, IEC 60601-x Expertise in EUMDR/IVDR regulations and compliance (across countries)

    noun_Processing_4022537
    noun_Processing_4022537

    Proven Processes and Methodologies

    Mature product and system V&V methodologies and in-house-developed IPDP process

    noun_Processing_4022537
    noun_Processing_4022537

    In-House Testing Labs

    Fully equipped test labs(power electronics, digital, RF, and communications) with state-of-the-art equipment

    noun_Processing_4022537
    noun_Processing_4022537

    Development of ATE

    Design and development (including mfg.) of Automated Test Equipment(ATE)

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    Over the last two decades, we have partnered with customers to address key challenges around:

    Plan and design Network
    Scaling V&V Expertise Quick ramp-up of core and flexible capacity across geos to support various levels of testing for critical programs
    Cybersecurity Verification and validation of legacy product line of patient-monitoring system to meet FDA's cybersecurity guidelines
    Regulatory Compliance Risk-based V&V of Class III Automated External Defibrillator to ensure compliance with all regulatory standards

    Our V&V Offerings

    Our V&V factory addresses the challenges that companies face during the V&V life cycle.

    V&V Factory Offering

    WorkFlowV-V

    Test workflow automation and test case orchestration

    Automation_of_multisite_and_parallel_execution

    Automation of multisite and parallel execution of test cases

    Testing Script

    Test script automation

    Testing repotrs

    Auto generation of test reports in multiple formats

    Virtual_Testing-1

    Virtual testing of models and software

    ADDRESSING KEY CHALLENGES

    Challenge

    Efficiency and Skill Gap

    Challenge

    Test Execution Orchestration

    Challenge

    New Technology Adaption

    Challenge

    Work Flow Streamlining

    Challenge

    Test Execution and Reporting

    Challenge

    Physical Device Dependency

    Our product V&V strategy includes early adoption in the life cycle, addressing all levels (unit/component to system level) with automation engrained to address product requirements and specifications.

    Product | Cyient

    Product

    Product_development
    Product
    • Functional validation. OTS/COTS verification, system reliability analysis
    • Regulatory compliance, safety, and essential performance
    • Co-existence testing, environmental testing, usability testing, biocompatibility
    • Documentation—compliance reporting
    Product
    Software | Cyient

    Software

    Software_Development
    Software
    • Static analysis, unit testing
    • Integration (manual/automated)
    • Regression (manual/automated)
    • Functionality (manual/automated)
    • System testing (manual/automated)
    • Usability testing
    • Tool qualification
    Software
    Hardware | Cyient

    Hardware

    EMBEDDED HARDWARE ENGINEERING
    Hardware
    • EMI/EMC testing
    • Hardware fault insertion testing. reliability testing, failure modes and effects analysis. hardware test coverage analysis
    • Test infrastructure development
    • Interface testing. leakage current and electric loading. magnetic field
    Hardware
    Test Automation | Cyient

    Test Automation

    regression_testing
    Test Automation
    • Consulting services—testing strategy, tool assessment, and selection
    • Transformation services—test automation implementation, testing optimization
    • Documentation services—compliance report generation
    Test Automation
    Img_Cyi_Tel_Sec02_Bnr-min

    Technology Accelerators

    set-top-boxes

    CertBENCH

    Test Automation Platform

    • Proprietary platform for automated testing against target hardware to detect errors (integration level)
    • Modular and scalable platform consisting of backplane, control and I/O board
    • Configurable automated test environment
    • In-circuit functional testing at CCA and LRU levels
    • Stimulus and data acquisition at a rate of hundreds of microseconds
    • I/O boards for ARINC 429, 708, Analog, Discrete, Ethernet

    CyFast-1

    CyFast

    Framework for Automated System Testing
    90% automation
    50% faster time-to-market
    30% cost savings

    • AI-powered, end-to-end system test automation platform
    • Single framework for testing across platforms such as embedded, web, mobile, desktop, API, and simulators
    • Enables use of existing automation assets for end-to-end solution testing
    • Risk-based impact analysis for prioritizing test case execution and planning
    • Integration with ALM tools to update test cases, test scripts, test execution results, and traceability.
    • Enables multisite and parallel execution of test cases

    Know More

    Technology Accelerators

    Cyient Framework for Automated System Testing

    • AI-powered, end-to-end system test automation platform
    • Single framework for testing across platforms such as embedded, web, mobile, desktop, API, and simulators
    • Enables use of existing automation assets for end-to-end solution testing
    • Risk-based impact analysis for prioritizing test case execution and planning
    • Integration with ALM tools to update test cases, test scripts, test execution results, and traceability.
    • Enables multisite and parallel execution of test cases

    90% automation
    50% faster time-to-market
    30% cost savings

    CyFast Know More

    Test Automation Platform

    • Proprietary platform for automated testing against target hardware to detect errors (integration level)
    • Modular and scalable platform consisting of backplane, control and I/O board
    • Configurable automated test environment
    • In-circuit functional testing at CCA and LRU levels
    • Stimulus and data acquisition at a rate of hundreds of microseconds
    • I/O boards for ARINC 429, 708, Analog, Discrete, Ethernet

    CertBENCH

    CertBENCH

    In-House Test Labs

    Our test infrastructure/in-house labs enable us to deliver best-in-class quality products.

    Image7__IG2_Agri

    Power Electronics Lab
    (6000 sq.ft)

    Lab equipment to enable development of power products up to 22.5 kVA (DC-DC converters, inverters, power distribution boxes, actuation, battery management, etc.

    Image7__IG2_Agri

    Digital Lab
    (3000 sq. ft.)

    Lab equipment, tools, and simulators to enable the development of high-speed boards (analog, digital, mixed, and RF), FPGA, processors, LRU level test setup

    Image7__IG2_Agri

    RF and Communications Lab
    (6000 sq. ft.)

    Calibrated test equipment and simulation tools to enable development of navigation, radars, communications systems up to <26.5 GHz

    Explore our labs

    Success Stories

    Electronic hardware redesign and verification of low temperature freezers comprising smart features that enable hospitals/labs safeguard patient specimen samples and reduce warranty claim costs

    Value Delivered

    • Compatible with legacy product
    • Edge/modular design for backward compatibility
    • Predictive analytics for failure detection and maintenance
    Clinical_Analyzer

    End-to-end product development of a next-gen clinical analyzer that is capable of processing eight samples for 40 parameters

    Value Delivered

    • Manufacturing localization
    • 25% overall cost reduction
    • NRE cost reduction
    • Compliance testing/certification
    Freezer-casestudy

    Complete V&V of Class Ill Automated External Defibrillator meeting all regulatory standards leveraging risk-based V&V

    Value Delivered

    V&V ensuring safety compliance as per:

    • IEC 60601-1 3rd edition/UL/CE/ ISO13485/FDA/WEEE
    • IEC 62304 and ISO 14971 risk management
    Defibrillator

    Cybersecurity testing for networked patient monitoring system, as per FDA guidelines

    Value Delivered

    • V&V for four products, with complete documentation for 510(k) approval
    • Ensured legacy product lines' compliance with FDA's cybersecurity guidelines
    Cybersecurity

    Design, development, and manufacture of automated test equipment (ATE) for Non-Invasive Blood Pressure Monitoring System (NiBP) hose assembly

    Value Delivered

    • Designed hose with ability to test leakage of 1mm of Hg at an input pressure of 150mm of Hg in 30 sec
    • Capable of testing 5 hoses at a time(independently)
    • Intuitive UI with LCD as well as LED indications
    NiBP
    Talk_to_Us

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    Request for services

    • CYIENT

      Cyient (Estd: 1991, NSE: CYIENT)delivers Intelligent Engineering solutions for Digital, Autonomous and Sustainable Future

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