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product design

Quality and Compliance

BioTek strives to exceed customer expectations by continually improving the quality of our products, both by obtaining key quality certifications and by offering tools for our customers that help maintain compliance within their own laboratory.

Certifications

EN ISO 13485 Certification

BioTek maintains certification to EN ISO 13485. EN ISO 13485 defines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 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 cGMP (current Good Manufacturing Practices) Quality System Regulations set by the FDA for both instrumentation and software development. Some of our products are labeled "for in vitro diagnostic use", others have configurations available for in vitro diagnostic use.

CE Certification

The CE Mark signifies that BioTek products follow the requirements set by the European Union’s Directives applicable to our types of devices at time of manufacture.

Low Voltage Directive:

TÜV SÜD America IEC/EU/US/Canada Certification. With this combined certification, BioTek ensures that instruments meet North American and International safety requirements. Product type testing ensures compliance with the Low Voltage Directive 2014/35/EU.

Electromagnetic Compatibility (EMC) Directive 2014/30/EU:

Testing at BioTek and at a NRTL/EU recognized EMC Facility ensures that instruments do not emit excessive radio frequency signals and are less likely to be subject to interference like ESD or line surges.

RoHS Directive 2011/65/EU:

We have removed or reduced hazardous materials in all of our instruments making them compliant with the RoHS Directive.

IVD Directive 98/79/EC for in vitro diagnostics:

When we satisfy all of the requirements set by the Directive (98/79/EC), BioTek is able to label our in vitro diagnostic products with the IVD label.

Certification of Compliance and Calibration

Each BioTek product comes with its own form certifying that the instrument was inspected and calibrated in accordance with published specifications of BioTek Instruments, Inc. The accuracy 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.

Product Validation and Qualification Tools

Instrument Qualification (IQ/OQ/PQ) Procedures

BioTek offers a complete menu of Product Qualification Packages for all of our microplate instruments. Within each package, you’ll find detailed:

  • Product specifications
  • Qualification interval guidelines
  • IQ/OQ/PQ validated test plans and procedures
  • Data sets (where applicable
  • Qualification checklists and log sheets for complete documentation
  • Preventive maintenance guidelines

Software Validation

A Validation Package is available for Gen5 Data Analysis Software to allow testing and validation of key functions within Gen5 and Gen5 Secure. Included in the easy-to-use package are:

  • Test plans
  • Results checklists
  • Data sets and Gen5 protocols

Performance Test Plates

BioTek offers several test plates that facilitate instrument qualification testing, eliminating the need for time-consuming liquid testing.

Absorbance Test Plates:

Ensure GLP/GMP compliance by checking instrument absorbance performance against specifications for:

  • Accuracy
  • Repeatability
  • Linearity
  • Wavelength accuracy (for monochromator-based systems)

Fluorescence Test Plates:
This product is ideal for quick monitoring of fluorescence intensity between more thorough instrument qualifications. The Fluorescence Test Plate aids in maintaining GxP compliance by automatically checking a series of critical performance parameters, including:

  • Alignment
  • Cross talk
  • Signal-to-noise ratio
  • Linearity
  • Precision

The Fluorescence Test Plate can be used with all Cytation and Synergy readers equipped with fluorescence detection.

Luminescence Test Plates:
NIST-traceable Luminescence Test Plate for use with the applicable Product Qualification Package or updated User’s Manual. Features of the Luminescence Test Plate include:

  • NIST-traceability certificate, which guarantees a controlled light output from the test plate
  • Simple design, easy to use: just turn the plate on, and read the ultra-stable, low light level LEDs

 

Test Plate Recertification Programs are available. Please contact BioTek Service at TAC@biotek.com for details.

 

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