Today, laboratory personnel must meet increasing regulatory pressures, higher quality assurance standards, and rapid technological growth, while performing their work faster and more efficiently than ever. BioTek stands behind you ready to provide a full range of microplate instrumentation and intuitive software applications to meet today’s and tomorrow’s challenges. The following Product and Quality System Certifications are just some examples of our commitment to excellence:

ISO 9001 Certification
BioTek maintains a Quality System that is certified to ISO 9001 and ISO 13485.

ISO 9001 defines quality systems for design, development, production, installation, testing, inspection, and service and support of products. ISO 9001 certification emphasizes BioTek’s continued dedication to continuous improvement and customer satisfaction.

FDA Compliance
As an FDA registered medical device manufacturer, BioTek follows the guidelines of GMP (Good Manufacturing Practices) Quality System Regulations set by the FDA for both instrumentation and software development. Our products are labeled "for in vitro diagnostic use".

CE Certification
The CE mark signifies that BioTek products have been designed and tested with environmental, safety and other regulatory requirements in mind. Product type testing ensures compliance with EEC Directives such as:

• Low Voltage Directive 73/23/EEC
• Electromagnetic Compatibility (EMC) Directive 89/336/EEC

ETL Listing
By obtaining this combined listing, BioTek meets North American and International safety requirements.

IQ/OQ/PQ Procedures
BioTek is committed to meeting customer needs with respect to qualification testing of instrumentation in laboratories. We have developed procedures to assist in the confirmation of initial and ongoing performance of our products. The Universal Test Plate is an important part of this confirmation process, allowing quick NIST traceable confirmation of optical density accuracy, linearity and plate alignment.

Certification of Compliance and Calibration
Each BioTek product comes with its own form certifying the instrument was inspected and calibrated in accordance with published specifications of BioTek Instruments, Inc. The accuracy and calibration of the test equipment utilized is directly or indirectly traceable to the U.S. National Institute of Standards and Technology (NIST), or other national standards, through calibration at planned intervals.