Testing and Analytics

Bertrandt Medical provides a broad range of services in the field of Testing and Analytics: from carrying out demanding tests and the statistical evaluation of the results to the development of new testing methods based on your requirements.

In addition to DIN EN ISO 13485, we also implemented the requirements of DIN EN ISO/IEC 17025 in our test laboratory D-PL-21811-01 in Ginsheim-Gustavsburg and we are accredited for the determination of dosing accuracy according to DIN EN ISO 11608-1.

Examples of our services in Testing and Analytics:

  • Development, validation, and transfer of methods
  • Product verification (function testing)
  • Data evaluation and analysis
  • Equipment and plant qualification DQ, IQ, OQ, PQ
  • Usability testing
  • System testing
  • Testing according to the DIN EN ISO 60601 series
  • Accredited testing (see certificate)

 

Reliable Testing for Needle-Based Injection Systems

Needle-based injection systems require the highest levels of precision, safety, and compliance with standards. We support companies in the pharmaceutical and medical technology industries with a comprehensive portfolio of services—from development and validation to method transfer tailored to individual customer requirements.

  • Testing & Analytics according to DIN EN ISO 11608-1 in our accredited testing laboratory*
  • Measurement of dosing accuracy and statistically sound analysis of all collected measurement data
  • Testing of mechanical functional parameters according to ISO 11040, such as needle penetration force, container closure integrity, break-loose and glide force, as well as activation/breaking force
  • Pre-treatment (mechanical and thermal) and transport simulation
  • Investigation of returned pens and autoinjectors
  • Design and product verification of combination products
  • Quality management in accordance with DIN EN ISO 13485, DIN EN ISO 17025, and GxP
  • Our accredited testing laboratory delivers reliable, standards-compliant results—for regulatory compliance and market-ready medical technology.

*Testing laboratory accredited by DAkkS in accordance with DIN EN ISO 17025:2018. The accreditation applies only to the scope of accreditation listed in certificate annex D-PL-21811-01-00

ISO/IEC 17025 Accreditation

Your Contact

Ulrich Schatz

Key Industry Manager