HRB – CRCI: Supporting early stage MedTech companies to conduct clinical investigations in Ireland by providing guidance on International Regulatory, Clinical and Quality compliance

 

  • Enabling MedTech researchers and companies to advance to Clinical Investigation of medical devices in Ireland
  • Providing Overarching Support and Coordination of Multi-Centre Clinical Research Activities

 

Services:

  • Advice on early stage product classification
  • Regulatory pathway development advice
  • Signposting on QMS; particular requirements for start-up companies
  • Advice on Design Control and Risk Management while developing Medical Devices
  • Linkages to information resources
  • Support services to Clinical Research facilities
  • Advice on Medical Device Regulations
  • Advice on international standards ISO 13485, ISO 14155, ISO 14971

HRB-CRCI Support Documents

Contact Fiona Campbell, Clinical Industry Liaison Officer, for information on the documents below or any other related topic.

A beginners overview of Medical Device Classification under the MDR

An overview of Design Controls as they apply to Medical Devices

EU Topics of interest page

EU Medical Devices

HPRA:  EU MDR/IVDR Legislation

What is ISO 13485?