Regemon LLC
  Regulatory Affairs and Quality Systems Consulting
                EU (CE) Compliance  
  •          Preparation of Technical Files and Design Dossiers
  •          Assistance in the implementation of a Quality System in compliance with ISO 13485: 2016 and EN ISO 14971: 2012
  •          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/ IVDD)
Welcome Regulatory Compliance Quality Systems Training EU (CE) Compliance Resources Contact Us

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