Medcore Suisse GmbH

1 Regulatory consulting for the Medical Devices (non IVD) industry:

  • CE marking of conformity
  • Supporting development process for regulatory compliance
  • Supporting and advising readiness for compliance with new MDR
  • Act as RA responsible person for ECREP organisations
  • EMEA / APAC submissions
  • Technical file / Design Dossier writing and assembly, according to STED / CSDT format
  • Clinical studies for compliance with MDR

All risk classes supported, including AIMD

2 Supplier and distributor audits (worldwide) for compliance with ISO 13485, issues 2003, 2012 and 2016