Certificates - Biotek ( Chetan Meditech Pvt. Ltd.)

Certificates

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

ISO 9001:2008     Quality management systems – Requirements
ISO 13485:2003   Medical devices - Quality management systems - Requirements for regulatory purposes
MDD 93/42/EEC    Council Directive concerning Medical Devices

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 9001: 2008

ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM-REQUIREMENTS(CERTIFICATE SCAN ATTACHED)

ISO 13485: 2003

ISO 13485: 2003 MEDICAL DEVICES-QUALITY MANAGEMENT SYSTEM-REQUIREMENT FOR REGULATORY PURPOSES(CERTIFICATE SCAN ATTACHED)

MDD 93/42/EEC (CE MARKING) FOR CLASS IIb PRODUCTS

MDD 93/42/EEC (CE MARKING)-EUROPEAN COUNCIL DIRECTIVES CONCERNING MEDICAL DEVICES

(CERTIFICATE SCAN ATTACHED)

MDD 93/42/EEC (CE MARKING) FOR CLASS IIb PRODUCTS

MDD 93/42/EEC (CE MARKING) FOR CLASS III PRODUCTS

MDD 93/42/EEC (CE MARKING)-EUROPEAN COUNCIL DIRECTIVES CONCERNING MEDICAL DEVICES

(CERTIFICATE SCAN ATTACHED)

MDD 93/42/EEC (CE MARKING) FOR CLASS III PRODUCTS