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Awards & Memberships

Our Certifications

BIOTEK maintains a quality management system which is regularly certified in accordance with the following international standards.

These standards make the development, manufacturing and supply of products and services at BIOTEK more efficient, safer and cleaner and provide us with a technical base for health, safety and environmental regulations, helps us in technological advances and maintaining good management practices, disseminates innovation, safeguards consumers, and users in general, of our products and services and last but not the least makes life simpler by providing solutions to common problems.

ISO Certification

   
ISO 9001:2008 Quality management systems.

ISO Certification

   
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes.

ISO Certification

   
ISO 10002:2004 Quality management systems-Customer Satisfaction.

Quality Certificates

   
CE marking- MDD 93/42/EEC Council Directive concerning Medical Devices.

Certificate of Registration

Awards & Memberships
Since our establishment, we have always maintained a quality management system that is
regularly certified in accordance with the following international standards. We are a certified
company with several quality certifications that make development, manufacturing and supply
of products and services at our company efficient, safe and clean. This further ensures a
good technical base that is vital for health, safety and environmental regulations.
List of awards & memberships:
¿¿¿ ISO 9001: 2008 Quality Management Systems
¿¿¿ ISO 13485: 2003 Medical Devices- Quality Management Systems
¿¿¿ ISO 10002: 2004 Quality Management Systems
¿¿¿ CE- Design Certificate for Class III Products
¿¿¿ CE- Certificate for Class III Products
¿¿¿ CE Certificate for Class IIb Products
¿¿¿ Manufacturing Drug License issued by Indian FDA


Reach Us
Shweta Patel (Director)
Opposite V. S. Hospital, Ellisbridge
Ahmedabad- 380006, Gujarat, India



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