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366 results:
IT security for “legacy devices”  
IT security for “legacy devices” Understandably, laws and standards also require IT security for “legacy devices." However, the way in which these requirements are formulated often leads to confu  
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Unique Device Identification UDI: What We Must Face  
Unique Device Identification (UDI) in the EU With the UDI system, the EU has introduced an obligation to identify and register medical devices that goes far beyond what is still required under the  
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Developing a regulatory strategy: 6 good reasons  
Developing a regulatory strategy: 6 good reasons Defining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers.  Why is  
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Market Access of Medical Devices in China  
CFDA, NMPA: Approval of Medical Devices in China The CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which  
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Transitional Periods MDR, regulatory requirements  
MDR transition periods In Article 120, the MDR establishes its transitional provisions, including the transition periods. However, the descriptions of these transitional provisions and transition p  
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Market Access of Medical Devices in Japan  
Market Access of Medical Devices in Japan Tuesday, May 12, 2020 The authorization of medical devices in Japan represents a big challenge for European manufacturers. But it’s not one they should s  
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Importers: What Do the MDR and IVDR Actually Demand?  
Importers: What Do the MDR and IVDR Actually Demand? The EU regulations the MDR and IVDR set out precise requirements for importers. And they also define who is an importer. Bringing a device int  
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Performing FDA Recalls Correctly  
The process for FDA recalls, corrections and removals for medical devices, when they are used, and what to pay attention to.  
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The FDA eSTAR Program: should or must you take part?  
The FDA eSTAR Program: should or must you take part? With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g. the 510(k) procedure) through digitalization. Thi  
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Devices without an intended medical purpose - Annex XVI devices  
Devices without an intended medical purpose - Annex XVI devices The EU Medical Devices Regulation (MDR) regulates not only medical devices, but also devices without an intended medical purpose  
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