ISO 13485 Quality Management
Our quality management system is certified to ISO 13485:2016, the international standard for medical device manufacturing.
Manufacturing & quality
Engineering precision. Delivering confidence.
Quality is at the heart of everything we manufacture. From raw material selection to final product release, every stage is guided by controlled processes, rigorous inspection, and a commitment to continuous improvement.
CONTROLLED PROCESSES ·
DOCUMENTED RELEASE17,296 sq ftIntegrated facility
Class 7 & 9ISO cleanroom environments
In-houseValidated EO sterilization · ISO 11135
ISO 13485Certified quality management
01OUR FACILITY
Purpose-built manufacturing
A purpose-built home for precision manufacturing.
Our 17,296 sq ft integrated manufacturing facility in Natham, Dindigul, Tamil Nadu, is designed and equipped to international standards — bringing cleanroom production, in-house sterilization and quality control under one roof.
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Quality systems
Controls that travel with every batch.
Regulatory Compliance
CDSCO approved facility, compliant with Indian MDR 2017 and aligned with EU MDR 2017/745 requirements.
Process Validation
Manufacturing processes are validated to support consistent, repeatable outcomes batch after batch.
Risk Management
Systematic risk assessment is embedded across product design and manufacturing processes.
Certifications & documents
Documentation for your review.
FACILITY APPROVAL
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CDSCO Manufacturing Licence
Our facility is approved by the Central Drugs Standard Control Organisation (CDSCO) for the manufacture of ophthalmic medical devices.
QUALITY MANAGEMENT
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ISO 13485:2016 Certificate
Our quality management system is certified to ISO 13485:2016, the international standard for medical device manufacturing.
REGULATORY STATUS
In progress
CE Marking
Facility and quality systems are being prepared to meet EU MDR 2017/745 requirements for CE marking.
Built for global compliance
Infrastructure designed to support evolving regulatory pathways.
As Eyegen continues to expand its regulatory footprint, our manufacturing infrastructure, cleanroom environments and ISO 13485:2016 quality management system are designed to support the rigour required by EU MDR 2017/745 and US FDA pathways. This provides a foundation as we pursue relevant certifications and registrations for our product range.
Technology & know-how
Precision shaped by process.
Precision Flat-Strip Construction
In-house blade and component manufacturing built on precision flat-strip construction for consistent geometry.
Automated Edge-Forming Technology
Advanced automated grinding technology delivers consistent, repeatable edge formation across every unit.
Ultrasonic Welding Assembly
Component assembly using ultrasonic welding technology for a stable, reliable bond — in-house, not outsourced.
Surface Treatment Technology
Specialised surface treatment processes engineered to reduce drag and improve performance in use.
Why choose Eyegen
Precision
ManufacturingReliable
QualityConsistent
PerformanceTrusted Worldwide
Explore Eyegen Medical
See the precision behind every product.
Explore our portfolio, or talk to our team about your specific requirement.