Medical devices contaminated with pathogens may be a source of infection for humans. Therefore, according to the Medical Device Directive, devices must be designed and manufactured in such a way as to eliminate or reduce the risk of infection to the patient, user or third parties as far as possible.
Consequently, medical device manufacturers, in particular if they manufacture sterile devices, must produce their products under adequate and microbiologically monitored conditions involving a clear zone concept. Furthermore, the final products, and if necessary the starting and packaging materials, must be subjected to bioburden determinations in order to support the later sterilization success. For devices with an invasive application endotoxin testing is necessary in order to evaluate the potential risk that the device may cause fever reaction during application.
The microbiological basic tests of “UL MDT” inform the manufacturer about the microbiological status of their products, determine anti-infective properties of materials and disinfectants and help to control manufacturing processes and sterilization procedures.
What we offer:
- Bioburden Determinations
- Sterility Testing
- Differentiation and Detection of Pathogenic Microorganisms
- Endotoxin Testing (LAL Test)
- Antimicrobial Activity Testing
- Microbiological Monitoring of Production