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ISO Certificate Roche CustomBiotech in Penzberg, Germany

The CustomBiotech Quality Management System (QMS) is certified according to ISO 13485.
This international standard requires an organization to consistently meet customer and regulatory requirements specifically applied to the in-vitro diagnostic and medical device industry.

Download ISO 13485:2016 certificate here

CustomBiotech raw material and final kit production follows:

  • Detailed documentation (SOPs)
  • Independent QC and QA departments
  • Change control procedures
  • Batch records with full traceability of all parameters
  • Complaint handling procedures
  • Education and training programs
  • Supplier evaluation programs
  • Maintenance and calibration programs


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