Manufacturers of in vitro diagnostic Medical Devices must face important news provided for in the Regulation on in Vitro Diagnostic Medical [...]
When the transitional period will end, all the IVDs to market in the European Union will have to satisfy the requirements [...]
In Vitro Diagnostic Medical Devices Manufacturer, according to risk classes, have the following transition periods available for the application of IVDR [...]
The in Vitro Diagnostic Medical Devices Regulation(EU) 2017/746 IVDR rules the in Vitro Diagnostic Medical Devices marketing, provision, and commissioning on [...]
The Medical Device Single Audit Program (MDSAP) allows Auditing Organizations (AO) recognized and accredited by the Regulatory Authorities of the five [...]
The "period of grace" is the time interval, which coincides with the due date, during which a CE certificate issued pursuant [...]
The "market surveillance" (performed by the Competent Authority) is the set of activities carried out and the measures taken to verify [...]
To monitor the traceability of Medical Devices throughout the supply chain, the European Regulations place not only more stringent requirements for [...]
The post-market surveillance system (PMS) serves to “collect, record and actively and systematically analyze the relevant data on the quality, performance [...]
The MDR certificate is a new certification and not an amendment of the Medical Device Directive (MDD) 93/42/EEC. However, pending the [...]
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