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Accelerating Medical Device Development for a Connected Tomorrow

Building intelligent healthcare technologies

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The Partner You Need in the Medical Device Development Journey

Cyient’s expertise sets your product apart through research and innovation.

In the swiftly evolving landscape of medical devices, the conventional paths of research and development no longer lead to excellence. The medtech industry contends with shifting market trends, stiff competition, and rapid globalization, necessitating a fresh operational approach. This involves automating and managing end-to-end business processes, addressing challenges like streamlined product lines and digital transformation while controlling costs. Thriving in this globally regulated environment hinges on surmounting these challenges to maintain a market leadership.

Cyient plays a pivotal role in helping leading corporations, device manufacturers and healthcare companies with a comprehensive suite of solutions. We augment and support product development, manufacturing, and regulatory compliance, tailored to a diverse clientele, all underpinned by our 30-year legacy of excellence. Our deep understanding of healthcare reforms and technological leaps allow us to help businesses keep up with demand for pioneering medical devices.

Offerings that accelerate medical device development

Wide range of services that make us the Partner of Choice

Product Engineering

Quality Assurance

Regulatory Compliances

Digital Health

product engineering

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

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

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

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

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
digital health

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

FHIR
Connected Care
SaMD
IoMT

Offerings That Accelerate Medical Device Development

Wide range of services that make us the Partner of Choice

Product Engineering

Quality Assurance

Regulatory Compliance

Digital Health

Innovating medical devices 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 device 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
SaMD
IoMT

Our Success Stories

Pupilometer

Developed New Product- Pupilometer

Rapid, CE-compliant product development using Agile methodology. Addressed challenges in quantifying responses to light stimuli, progress monitoring, and data analysis. Achieved end-to-end development, AWS-based solution, and CE pre-certification.

ULT Freezers

Redesigned ULT Freezers completely

Developed a smart sensor-based Ultra Low Temperature (ULT) freezer system for hospitals/labs, entailing design, integration, and verification. A retrofit edge device was created to enable smart features, ensuring specimen safety and minimizing warranty claim costs.

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Cyber Security of Patient Monitoring Devices

Enhanced cybersecurity for 4 patient monitoring devices, aligning with FDA guidelines. Strengthened system by addressing cyber vulnerabilities, ensuring confidentiality of EHRs. Achieved FDA compliance through NIST and CVSS frameworks.

Success stories in healthcare

See how Cyient drives transformative impact for medical device manufacturers

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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.

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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.

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Find out more about how you can maximize impact through our services and solutions.