:::Biotek::: | Certifications

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.

Please click on the links below to see the quality certificates.

Drug   Manufacturing License issued by the State FDA(Food and Drug   Administration) office under approval of the CLAA(Central License   Issuing Authority)and endorsed by the Drug Controller General of India

ISO 9001:2008             Quality management systems - Requirements

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

ISO 10002:2004           Quality management systems - Customer Satisfaction

MDD 93/42/EEC          Council Directive concerning Medical Devices

                                                - For Class I products

                                                - For Class IIb products

                                                - For Class III products

MDD 93/42/EEC          EC Design-Examination certificate

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Certifications

COMPANY
Our Business
Biotek Strategy
What we do
Precision Manufacturing

PRODUCTS
Arthroscopy
Spine
Shoulder
Elbow
Hip
Trauma
External Fixation
Instrument