Verification and Validation of Medical Devices | Cyient

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.

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

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

Embedded CoE/ V&V Factory

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

Solution Accelerators

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

Expertise in Regulatory Compliance

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

Proven Processes and Methodologies

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

In-House Testing Labs

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

Development of ATE

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

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

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Technology Accelerators

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

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

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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.

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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

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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

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

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

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