http://www.nouvelle-chouannerie.com/kloynada/1005 Last week UDI Global Solutions attended and exhibited at the 2017 EU MDR & IVDR conference.
http://racingcitychorus.org/filmo/3962 The conference served to bolster our contention that there will be many new requirements coming from regulations in the EU and elsewhere that will have to be dealt with in the next few years. Here are three main take aways from the conference …
code ar rencontrer pokemon saphir 1) Check to make sure your Notified Body is still around and certified. A number of new requirements are coming into play for them as well as they will now be legally liable for the devices they cover.
2) The EU UDI deadline to upload device data to EUDAMED for singlebУЖrse kiel kostenlos all classes is May 26, 2020. (For Class I devices that is 4 months in advance of GUDID for the US)
3) Many new processes and activities have been added, however guidance documents for most of these are still in development so it is important to find someone internally or externally who can keep you updated as things develop.
29ème rencontre des musulmans de france The overarching theme coming from the conference was that compliance with these and other UDI requirements is not a como conocer chicas del extranjero project but an ongoing partnersuche neustadt in holstein process. The need to add data for new devices, update existing device records to meet changes in the dataset, quality check new data as its added and maintain the most current device data for multiple authorities and trading partners (both regulatory and commercial) will constantly be evolving. Having a Master Data Management system for controlling these processes will be the key going forward, excel simply won’t suffice.
At UDI Global Solutions we have that system! We are distributors of the Kodit UDI Compliance Solution. Kodit is a cost-effective, secure, cloud based Master Data Management system that provides a tool set for medical device companies to gather, quality check, manage and submit their GS1 and UDI data to global trading partners.
Kodit further provides PEPPOL. PEPPOL (Pan European Public Procurement On-Line) will be a requirement to trade (ordering and invoicing standard) with all governments in the EU, UK, Australia, New Zealand, and many more countries. Our PEPPOL portal, built in partnership with IBM Global, is provided to our partners as part of the UDI solution. We also offer it as a stand alone system that provides for PEPPOL trading anywhere in the world for a nominal cost. You can see our stand alone PEPPOL pricing here.
For more information on Kodit UDI for global compliance or to learn how PEPPOL will affect your ability to trade globally please contact us at http://www.austincountyems.com/piknik/6947 firstname.lastname@example.org.