Certified Management Systems

ISO 9001 and QMS

Certificate Holder: GENSPEED Biotech GmbH

Test Mark Number: 0000058115

The certificate holder's Management System corresponds to standards:

  • EN ISO 13485:2016
  • ISO 9001:2015
The organization "GENSPEED Biotech GmbH" as named in the certificate was audited and certified by “TÜV Rheinland LGA Products GmbH“.
Certificate scopes:
  • ISO 9001:
    Design and development, manufacture and distribution of test kits and analysis instruments (including installation and service) for detection of various analytes in sample material.
  • QMS:
    Description see attachment Design and development, manufacture and distribution of detection of nosocomial infections, periodontitis and molecular diagnostic test kits and instruments for the peri-implantitis. Installation and service of instruments.
Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: GENSPEED Biotech GmbH

Gewerbepark 2, Gebäude B
4261 Rainbach