Kiwa as an independent quality organization with highly qualified certification, inspection, testing, technology, training, and data services activities, offers in the field of medical devices a complete certification procedure, assuring a constant support during the entire development of the process, as well as evident savings for what concerns duration and supply costs of the service.
Moreover, in order to support the manufacturer, Kiwa provides an equipped laboratory, which is accredited for the execution of the necessary tests in order to achieve the CE mark.
Discover more on the new Medical Devices Regulation
The new MD Regulation will replace the 93/42/EEC and the 90/385/EEC Directives and is now in technical and legal review. This regulation will introduce significant changes, for example: a strighter control on technical documentation a more stringent clinical evaluation and post-market surveillance and obligations also for importers and distributors.
This drafting process started on 2012 after a public consultation, will probably end on the first quarter of 2017 and the MDR will have a transition time of three years from publication.
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