The area of responsibility for manufacturers of medical products has expanded enormously in recent years. We have made it our task to provide manufacturers with an optimal support for the quality assurance of their medical products. We bundle hygiene-specific, technical and microbiological expertise and help you to design anoptimal strategy for the approval of medical devices.
Our services for manufacturers of medical products
We offer the following services according to the relevant norms and regulations:
Implementation of the new EU medical device regulation
- Support in the implementation of the new EU medical device regulation in your company
- Review of your quality management system according to the requirements of DIN EN ISO 13485
- Implementation of the standard DIN EN ISO 17664 for the approval of medical devices
Validation of cleaning and disinfection processes
We validate cleaning and disinfection processes of your medical device according to the specifications of all relevant standards and guidelines:
- Validations according to the series of standards DIN EN ISO 15883
- Validations according to the guidelines of the DGKH / DGSV and AKI
- Execution of cleaning and disinfection processes according to your individual requirements
- Various laboratory analyzes (e.g. determination of residual protein content)
- Microbiological determinations (e.g. with Enterococcus faecium test germ)
Validation of sterilization processes
We offer you the validation of the sterilization process Your medical device according to the following standards and guidelines:
- Validation according to DIN EN ISO 17665
- Validation according to the specifications of DIN SPEC 58929 and DIN EN 13060
- Tests according to the recommendations of the DGKH
- Execution of sterilization processes according to your individual requirements
- Microbiological determinations (e.g. with test germ Geobacillusstearothermophilus)
Our service for you
We can also offer you support for the following topics:
- Material testing with regard to the maximum number of preparation cycles
- Performing cytotoxicity tests
- Studies on the biocompatibility of your product according to the requirements of the norm series DIN EN ISO 10993
