Validation of medical device processing for manufacturers: Project flow
The illustration shows a general project flow.
After the first request you send us the information and, if you like, the test specimens for the corresponding products. If available, instructions for preparation and use or illustrations are helpful to evaluate the test specimens.
After we reviewed all the information, we will discuss the required tests with you (Validation analysis). We would be happy to advise you on worst-case products or on providing a risk matrix template.
If there are no documents available regarding the processing, we will also support you in this regard. For example, assisting you by the creation of an ISO 17664-1 and -2 compliant processing instruction.
If preliminary tests or prototype tests have to be carried out before the reprocessing validation, this can also be implemented in our in-house Processing unit for medical products. This Processing unit for medical products consists of an ultrasonic bath, a Washer disinfector and a steam sterilizer.
Following the validation analysis, we will create an individual offer for you.
As soon as the test specimens have reached us, we discuss the critical points with you and start drawing up a validation plan. This Plan contains all information about the tests. After you approve the validation plan, we start with the tests to validate the processing.
After the tests have been completed, we create the validation report with the Data of the validation.
You will receive all documents as digital draft versions. The final versions then both in printed form and digitally. On request, we can also issue a free validation certificate.