Our sterilization validations meet current ISO/EN and FDA/ANSI/AAMI requirements specific to each form of sterilization. Our staff microbiologist will generate the protocol and submit it to you for approval. Once the protocol is approved and the necessary samples have been obtained, we manage the entire process including all laboratory testing and the necessary sterilization processing. Once the validation process has completed, we issue a complete final report which is totally self-contained and properly organized. Our final reports are ready for submission to the FDA or any other regulatory agency. We keep an extra copy of your report on file in case your copy is lost or destroyed.
Package Integrity Validation
Both the FDA and international regulatory bodies are focusing increasing emphasis on compliance with ISO 11607, Packaging for terminally sterilized medical devices. This standard defines test requirements necessary to insure that that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport or storage. Click here for more information on package validation services.
Let MDM handle your validation needs.
