MEDDEVCONSULTATION.COM

Our experts possess many years of experience in the preparation of such reprocessing instructions and are involved in the development and updating of the relevant standards at the national level. Our team thus combines many years of experience in the field of reprocessing validation for numerous diverse medical devices, from non-critical Class I products to Class III implants, as well as devices that place the highest demands on the reprocessing procedures due to their characteristics (e.g. endoscopes or minimally invasive instruments), as well as an understanding of the requirements for the relevant formulations in the instructions... When selecting products to form product groups, from which a "worst case" instrument is then selected, it makes sense to involve validation experts in the decision-making process at an early stage of the selection process in order to streamline the subsequent validation tests, reducing testing costs and decrease approval costs by unnecessarily..

Primary location: Schwerin Germany