Quality & Certifications

Meeting international quality standards for medical device manufacturing

9+ International Certifications

ISO 9001:2015

Quality Management System

International standard that specifies requirements for a quality management system. This certification demonstrates our ability to consistently provide products that meet customer and regulatory requirements.

ISO 13485:2016

Medical Devices - Quality Management

Specifically designed for medical device manufacturers, this certification ensures our products meet comprehensive regulatory requirements and maintain consistent quality in medical device production.

CE Marking

European Conformity

Indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Essential for export to European markets.

GMP

Good Manufacturing Practices

FDCA Gujarat certified facility following Good Manufacturing Practices ensuring products are consistently produced and controlled according to quality standards.

CDSCO

Central Drugs Standard Control Organization

Approval from India's national regulatory body for pharmaceuticals and medical devices, ensuring compliance with all Indian medical device regulations.

MDR-5 & MD-42

Medical Device Rules Compliance

Full compliance with Medical Device Rules ensuring all products meet safety and performance requirements set by Indian regulatory authorities.

Additional Recognitions

MSME-Udyam Registered

Startup India Recognition

Trademark (IP India)

MFG. Lic: MFG/MD/2023/000116

GUJ/MD-42/SUR/00097

RBS

FDCA GUJARAT

QMS

Our Quality Commitment

Every product leaving our facility undergoes rigorous quality control procedures. From raw material inspection to final product testing, we ensure that each item meets the highest standards of quality and safety.

100%

Batch Testing

Zero

Defect Policy

24/7

Quality Monitoring