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Driving development and growth of
In Vitro Diagnostics (IVD)

Transforming diagnostics for a better tomorrow

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Helping Build Products that Save Human Lives

Cyient accelerates product development through the technology-engineering convergence.

Navigating the intricate landscape of launching and sustaining in vitro diagnostics (IVD) products presents multifaceted challenges, particularly due to the dynamic and ever-evolving global regulatory framework designed to ensure patient safety. Adhering to these regulations necessitates a structured and adaptable approach, tailored to the unique product portfolios of manufacturers across various geographical domains.

The space of in vitro diagnostics (IVD) stands as one of the medical market's fastest-growing domains, propelled by the aging demographic and the corresponding surge in related medical conditions. Technological advancements have paved the way for innovative patient care avenues, exemplified by fully automated point-of-care (POC) instruments. These cutting-edge solutions empower healthcare providers to fine-tune treatment regimens, utilizing patient DNA and background information to prescribe precise drug dosages and combinations. In this dynamic landscape, Cyient's IVD services provide a strategic ally to manufacturers, assisting them in orchestrating successful product launches and sustenance within this regulated sector.

Offerings that accelerate in vitro diagnostics products

Wide range of services that make us the Partner of Choice

Product Engineering

Quality Assurance

Regulatory Compliances

Digital Health

Innovating IVD products for optimal safety and precision, blending advanced tech with user-centric design.

Concept Generation
Detailed Design
Verification & Validation
Prototype Development
Product Documentation
Design Transfer

Ensuring reliability through rigorous testing, upholding industry standards for consistent product performance.

Remediation
Corrective action/Preventive action
QMS Development
Product Design Control
Superior Quality Assurance Services
QSR Compliance with 21 CFR 820

Navigating global regulations, we deliver compliant medical solutions without compromising safety or efficacy.

IVDR & MDR Compliance
Country specific regulatory filings and submissions
Environmental compliance (RoHS, REACH, WEEE)
Risk management services per ISO 14971
Responding to FDA 483 observations, warning letters, and Notified Body audit findings
Post Approval Change Control

Empowering healthcare with secure, user-friendly digital solutions for remote monitoring and personalized care.

FHIR
Connected Care
IoMT

Offerings that accelerate in vitro diagnostics products

Wide range of services that make us the Partner of Choice

Product Engineering

Quality Assurance

Regulatory Compliance

Digital Health

Innovating IVD products for optimal safety and precision, blending advanced tech with user-centric design.

Concept Generation
Detailed Design
Verification & Validation
Prototype Development
Product Documentation
Design Transfer

Ensuring reliability through rigorous testing, upholding industry standards for consistent product performance.

Remediation
Corrective action/Preventive action
QMS Development
Product Design Control
Superior Quality Assurance Services
QSR Compliance with 21 CFR 820

Navigating global regulations, we deliver compliant medical solutions without compromising safety or efficacy.

IVDR & MDR Compliance
Country specific regulatory filings and submissions
Environmental compliance (RoHS, REACH, WEEE)
Risk management services per ISO 14971
Responding to FDA 483 observations, warning letters, and Notified Body audit findings
Post Approval Change Control

Empowering healthcare with secure, user-friendly digital solutions for remote monitoring and personalized care.

FHIR
Connected Care
IoMT

Our Success Stories

DEVELOPED

Developed New Product- Clinical Analyzer

Revamped architecture, motherboard, and 11 child boards, mitigating obsolescence. Achieved 20% cost reduction, crafted and tested all boards. Produced 5 prototypes, tailored for Indian manufacturing localization.

ivd_system

Point of Care IVD System

Developed a rapid POC real-time PCR diagnostics system for infectious diseases, implementing specialized production lines for efficient manufacturing. Achieved quick production ramp-up and cost reduction, ensuring competitive manufacturing costs.

sustain eng

Sustenance Engineering for Anatomical Pathology Diagnostics

Built the transfer system for automatic slide stainer to cover slipper for automation in the two downstream processes in a pathology laboratory under sustenance program with our CoE client

Success stories in healthcare

See how Cyient drives transformative impact for IVD manufacturers

wireless_personal_alarm_and_nurse_call_system
Wireless personal alarm and nurse call system

AnSem developed an ASIC that integrates a 40kHz UltraSonic receiver for room detection together with an RFID transceiver for room access and wandering prevention. An integrated 640 kHz PLL serves as a clock for the companion RF chip. The ASIC communicates through an SPI interface with this RF Link.

airplane
Aircraft vision system Analog Front End

ECSI came to AnSem for the design of an AFE that met the Xi-Channel® system requirements. A two die solution was devised with the PA and line interface designed in high voltage 0.18µm BCD CMOS and the remaining circuitry in 0.18µm CMOS to take advantage of the higher frequency transistors and lower power of this technology.

video
10 bit 100MSps pipeline ADC for video and SDR

The customer's ASIC was based on the standard TSMC 0.13µm CMOS. AnSem was asked to design the dedicated pipelined 10bit @ 100MSps ADC core because we had consistently exceeded the customer's expectations in previous projects. To optimize area and power AnSem used a 1.2V power supply and carefully scaled the different pipeline stages.

high_voltage_mems_array
High Voltage MEMS array

AnSem designed an ASIC containing all the supporting circuitry for the MEMS. On this ASIC, the MEMS array is postprocessed after regular CMOS silicon processing. Each MEMS is programmed by a control voltage with a range between -15V and +15V relative to the silicon substrate.

PDA
Ultra low-power RF CMOS ISM transmitter

AnSem developed an ultra low-power RF ISM transmitter in 0.25µm CMOS with an active power consumption of 2.6mW - <em>10 times lower than any other product available today. </em>The transmitter's low operating voltage - as low as 0.9V - and wide supply voltage range makes it possible to power it from a single alkaline battery.

energy_scavenging_ulp_transceiver
Energy scavenging ULP transceiver

To meet this market demand, AnSem developed an ultra low-power RF ISM FSK transceiver in 0.25µm CMOS with a operational voltage range 0.9 V to 1.6 V and a power consumption of 2.6mW for transmission / 1.2mW for reception.

35% completed

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