Our Services within the Medical Technology

We supports you in your efforts to comply regulatory requirements of the EU, Canada and the US; and to bring your medical device on the market.

This can be

  • MDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
  • IVDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
  • 510(k)
  • Clinical evaluation + PMCF
  • PMS / Vigilance processes
  • AU Authorized Representative + FSC (Free Sales Certificate)
  • Quality Management System (ISO 13485)

Please contact us for more information.

FullServiceModel MRM



  • UKRP-services
      The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person (UKRP) designated and registered at the MHRA, and take the responsibility for the product in the UK. The UKRP is the equivalent of an EU Authorised Representative. UK-based manufacturers need to appoint an EU Authorized Representative. UK comprises England, Scotland, and Wales. Northern Ireland is part of the UK, but…