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Regulatory developments and medical devices: issues and impacts, how to prepare for and adapt to them

Moderator A3P : Didier MEYER  
facilitators: Axelle CRESSENVILLE - SGS & Kim ROUAHI - Biotechni

The regulatory systems to which manufacturers of Medical Devices must subscribe, whether the product is disposable, implantable or even electronic, during their production and distribution are numerous and varied.
From 2017, these major repositories evolve for new directives involving the categorization of classes of Medical Devices on the one hand and the constraints that will now be associated with them as well.
From the development stages, the selection of raw materials, to the transport, the manufacturer will have to anticipate the rules to which he will henceforth be subjected.
The objective of this working group is to familiarize themselves with the regulatory developments under way and to understand and adapt them to each product or category of DM, in order to prepare the implementation for future inspections, placed on the market.

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