ISEMED COURSE LIST

Program

INTERNATIONALIZATION:

  • UDI – Unique Device Identification
  • Medical devices for international markets
  • FDA
  • Health Canada
  • CFDA
  • RUSSIA
  • South Korea
  • MDSAP

QUALITY:

  • New ISO 13485:2016
  • ISO 9001:2015
  • Process Validation and New ISO 13485:2016
  • Good Distribution Practice

EUROPA: LAWS AND REGULATIONS

  • 2017/745 Medical devices
  • Risks
  • Software validation
  • Clinical valutation
  • DM Usability
  • Electromedical devices
  • EN 62353
  • Biocompatibility

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