With the implementation of the European Union (EU) Medical Device Directive (MDR), many medical devices have been divided into more conservative categories than in the past. EUROLABcan help medical device manufacturers conduct testing to define the sterilization process, develop and execute sterilization validation protocols, map the necessary tests needed to validate the sterilization process, and ensure sterilization process monitoring and control.
When necessary, EUROLABcan provide clinical batch release processing to help manufacturers obtain batches of sterile medical devices for small-scale clinical use. (e.g. clinical trials)
The following services are available to assist manufacturers as they move from medical device design to conformity assessment stages:
EUROLABcan help manufacturers perform the tests necessary to define the sterilization process for medical devices. Our testing services that help process identification; includes comparative resistance testing, bioburden resistance testing, bioburden characterization, d-value testing of biomarkers and bioburden isolates, bioburden organism identification, functional exposures, and other non-routine testing services.
EUROLABCan help develop sterilization validation protocols and manage sterilization validation activities according to MDR. EUROLABoffers validation for multiple sterilization methods including:
EUROLAB Testing services include ancillary tests required to verify a sterilization process and to ensure continuous sterilization process monitoring and control. Testing services include:
The Clinical Batch Release is a widely used solution to deliver sterile product for clinical trials when device design is not final and complete validation is not required. This service is called a "mini-validation" that follows the same process but is less in scope. We can help you determine if the sterilization modality you are using allows for the sterilization of small batches of products.
EUROLAB, with its highly expert team and internationally accredited laboratories, Sterility Assurance Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
