Testing & Analytics: Reliable Testing Methods for Medical Technology
From conducting sophisticated tests to developing new testing methods: Bertrandt Medical offers a wide range of services in the field of testing and analytics for medical technology. Learn more about our accredited testing procedures.
Bertrandt Medical offers a wide range of services in the field of testing and analytics: from conducting sophisticated tests and the statistical evaluation of results to the development of new testing methods according to your requirements.
In addition to DIN EN ISO 13485, we also implement the requirements of DIN EN ISO/IEC 17025 in our testing laboratory D-PL-21811-01 in Ginsheim-Gustavsburg and are already successfully accredited for determining dosing accuracy according to DIN EN ISO 11608-1.
Examples of our range of testing and analytics services
- Development, validation and transfer of methods
- Product verification (functional testing)
- Data evaluation and analysis
- Device and equipment qualifications DQ, IQ, OQ, PQ
- Usability Testing
- System Testing
- Testing according to the DIN EN ISO 60601 series
- Accredited testing
Reliable testing for needle-based injection systems
Needle-based injection systems require the highest precision, safety and standards compliance. We support companies from the pharmaceutical and medical technology sectors with a comprehensive service portfolio – from development and validation to methodical transfer according to individual customer requirements.
- Testing & analytics according to DIN EN ISO 11608‑1 in our accredited testing laboratory
- Measurement of dosing accuracy as well as 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) as well as transport simulation
- Examination of complained pen and auto-injectors
- Design and product verification of combination products
- Quality management according to DIN EN ISO 13485, DIN EN ISO 17025 and GxP
Our accredited testing laboratory delivers reliable, standards-compliant results – for regulatory security and marketable medical technology.
Learn more about Testing & Analytics
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