Medical Devices Directive 93/42/EEC and FDA 21 CFR Part 11 regulations require testing systems used in the medical sector to be validated at regular intervals. A key element of the validation of processes in medical engineering and the pharmaceutical industry is the technical inspection of individual systems and instruments.
For the DQ, IQ and OQ stages in the qualification of materials testing systems, ZwickRoell assists customers by providing comprehensive, individually tailored qualification documentation in accordance with GAMP5 and current guidelines, as well as providing support during the actual on-site qualification procedure.
DePuy Synthes has taken advantage of this service for its ZwickRoell testing machine. "Consultation and support by ZwickRoell, together with performance of IQ/OQ on our materials testing machine, have all been delivered to our complete satisfaction. ZwickRoell staff give a highly competent impression and are responsive to the individual needs of their customers," states Roger Leist, Senior Project Manager, Material Science & Testing, at DePuy Synthes in Oberdorf.