Biotest Laboratories is FDA, ISO 13485, EN/ISO 17665 registered, and ISO/IEC 17025:2005 accredited.
FDA Registration
Biotest Laboratories, Inc. has been an FDA Registered company since 1988.
Last audited: March 18-March 25, 2009. No 483's issued.Click here for a printable PDF copy
Manufacturing: ISO 13485:2003
The ISO 13485 registration is provided to companies meeting the requirements for medical device quality management systems. An organization registered to 13485 must demonstrate its ability to manufacture medical devices and related services that consistently meet customer requirements.
Last audited: Facility relocation verification audit, May 6, 2010. No non-conformances cited.Click here for a printable PDF copy
Laboratory: ISO/IEC 17025:2005
Biotest Laboratories is accredited to the International Standard ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC 17025:2005 Laboratory Accreditation is the standard for laboratory technical competency, an effective quality system, and generation of technically valid test results. This accreditation covers bioburden, LAL, sterility, BI (biological indicator) testing, and cleanroom testing and certification.
Last audited: Re-accreditation audit, June 21-June 22, 2010. Two minor non-conformances cited.Click here for a printable PDF copy
Perry Johnson Laboratory Accreditation (PJLA) is processing our new certificate. During this interim period, PJLA has granted an extension to our current certificate until August 21, 2010. As soon as our new certificate is issued it will be made available to all our clients.
Steam Sterilization: EN/ISO 17665 (previously EN554)
Registration to EN/ISO 17665 relates to sterilization of medical devices; validation and routine control of sterilization by moist heat. Biotest Laboratories is registered as compliant with the requirements of ISO 13485:2003 for the provision of contract sterilization services for medical devices.
Last audited: Facility relocation verification audit, May 6, 2010. No non-conformances cited.Click here for a printable PDF copy
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