Laboratory Analysis
Basics
DOT GmbH has established a fully-equipped modern analytical laboratory for chemical analysis and microbiological-hygienic testing. Our highly qualified laboratory team consists of engineers, laboratory technicians and other skilled professionals. We are able to provide a wide range of testing services for stakeholders in medical and scientific institutions by combining professional expertise with technical capabilities.
We work according to GLP conditions and can draw on many years of experience as a DOT GmbH laboratory. We also offer specific support for optimum product development and successful market introduction.
Our analytical laboratory is certified according to DIN EN ISO / IEC 17025:2005-2008 and has been integrated into the quality management system of DOT GmbH that is certified in line with ISO 13485.
We work according to GLP conditions and can draw on many years of experience as a DOT GmbH laboratory. We also offer specific support for optimum product development and successful market introduction.
Our analytical laboratory is certified according to DIN EN ISO / IEC 17025:2005-2008 and has been integrated into the quality management system of DOT GmbH that is certified in line with ISO 13485.
Advantages for our customers
- Many years of experience in the field of laboratory analysis for own medical devices
- Modern technical equipment (e.g. HPLC, AAS, spectrophotometer)
- Timely and cost-effective implementation and documentation of the tests
- Vital synergies through collaboration with the R & D sector of DOT GmbH
- Availability of latest research findings due to partnerships with university collaborative projects
Range of Laboratory Analysis
Biocompatibility testing:
- Cytotoxicity testing
Microbiological-hygienic testing:
- Determination of total bacterial count (surfaces, air, water)
- Determination of the population of microorganisms on a product (Bioburden)
- Sterility testing
- Antimicrobial efficacy testing
- Bacterial endotoxin testing
Analytical methods (chemical/physical):
- Determination of particle contamination (invisible particles)
- Elemental determination using AAS
- Recording of FT-IR spectra
- Determination electrical conductivity
- Various photometric determinations
Your questions
Our laboratory team will be happy to help you with any questions you may have relating to testing medical devices, active ingredients and their starting materials as well as preparing risk analyses and clarifying quality management questions.