Medical Device Development Solutions

In the post-COVID era, medical device manufacturers face a rapidly evolving landscape that brings both significant challenges and transformative opportunities. Navigating this dynamic environment requires agility, innovation, and a deep understanding of emerging complexities. The fast-changing regulatory landscape demands continuous adaptation and resource investment to comply with evolving standards. At the same time, integrating advanced technologies requires a delicate balance between fostering innovation and ensuring reliability. The growing connectivity of medical devices has heightened vulnerabilities, making robust cybersecurity measures essential to protect sensitive data and maintain functionality. Additionally, the rapid pace of technological advancement accelerates product obsolescence, compelling manufacturers to innovate quickly while striving to stay relevant in a competitive market.

Cyient's deep industry expertise and commitment to innovation makes it the right partner to help you navigate these challenges and achieve success.

Intelligent Engineering with Cyient

Streamline

Optimize engineering processes and test automation to reduce costs and accelerate time-to-market.

Integrate

Enable smooth adoption of advanced technologies, ensuring connectivity with legacy systems to enhance product capabilities.

Comply

Achieve regulatory adherence, protect patient data integrity, and maintain reliable system operations.

Elevate

Improve decision-making, customer experience, and engagement while ensuring FDA compliance.

Building with Intelligent Healthcare Technologies

Product to Platform

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

Quality Assurance

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

Regulatory Affairs

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

Legacy Product Modernization

FHIR
Connected Care
SaMD
IoMT

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

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

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

FHIR
Connected Care
SaMD
IoMT

In the Spotlight

Accelerated CE-Compliant Development of a Clinical Analyzer

Cyient delivered a CE-compliant clinical analyzer with end-to-end development, leveraging Agile methodology to address light stimuli quantification, progress monitoring, and data analysis, culminating in an AWS-based solution and CE pre-certification.

Smart Redesign of ULT Freezers for Enhanced Specimen Safety

We transformed ULT freezers with smart sensor-based technology, integrating retrofit edge devices to ensure specimen safety, minimize warranty claims, and elevate operational efficiency for hospitals and labs.

Secured Patient Monitoring Devices to Meet FDA Guidelines

We fortified cybersecurity for patient monitoring devices, addressing vulnerabilities, safeguarding EHR confidentiality, and achieving FDA compliance through NIST and CVSS frameworks.

Intelligent Engineering

Accelerating Medical Device Development for a Connected Tomorrow

Intelligent Engineering with Cyient

Streamline

Integrate

Comply

Elevate

Building with Intelligent Healthcare Technologies

In the Spotlight

Accelerated CE-Compliant Development of a Clinical Analyzer

Smart Redesign of ULT Freezers for Enhanced Specimen Safety

Secured Patient Monitoring Devices to Meet FDA Guidelines

Make the shift to
INTELLIGENT ENGINEERING

Intelligent Engineering

Accelerating Medical Device Development for a Connected Tomorrow

Intelligent Engineering with Cyient

Streamline

Integrate

Comply

Elevate

Building with Intelligent Healthcare Technologies

In the Spotlight

Accelerated CE-Compliant Development of a Clinical Analyzer

Smart Redesign of ULT Freezers for Enhanced Specimen Safety

Secured Patient Monitoring Devices to Meet FDA Guidelines

Make the shift to INTELLIGENT ENGINEERING

Make the shift to
INTELLIGENT ENGINEERING