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
