Regemon LLC
 
 
  Regulatory Affairs and Quality Systems Consulting
 
  Welcome     Regulatory Compliance     Quality Systems     Training     EU (CE) Compliance     Resources     Contact Us  
         
 
                     EU (CE Marking) Compliance  
  •          Preparation of Technical Files and Design Dossiers
  •          Assistance in the implementation of a Quality System in compliance with EU MDR (incl.
        ISO 13485: 2016) 
  •          Interaction with Notified Bodies and Competent Authorities in the European Union
  •          Development and implementation of a compliant EU Vigilance System
  •          Training: CE Marking under Regulation (EU) 2017/745 [MDR] replacing EU Directives for
        Medical Devices (MDD/ AIMD)

 

 

 

 
     
         
 
  Welcome   Regulatory Compliance   Quality Systems   Training   EU (CE) Compliance   Resources   Contact Us
 
Contact Us: Christof Littwitz * +1.210.296-9236 * clittwitz@regemon.com
 

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