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.
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MDD 93/42/EEC (CE MARKING) | MDD 93/42/EEC (CE MARKING)-EUROPEAN COUNCIL DIRECTIVES CONCERNING MEDICAL DEVICES(CERTIFICATE SCAN ATTACHED) |
ISO 13485: 2003 | ISO 13485: 2003 MEDICAL DEVICES-QUALITY MANAGEMENT SYSTEM-REQUIREMENT FOR REGULATORY PURPOSES(CERTIFICATE SCAN ATTACHED) |
ISO 9001: 2008 | ISO 9001: 2008 QUALITY MANAGEMENT SYSTEM-REQUIREMENTS(CERTIFICATE SCAN ATTACHED) |
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Products
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