The NCTO Clinical Industry Liaison Officer (CILO), supported by Enterprise Ireland, will provide the following supports to MedTech Clinical Research:
- Provide Education and Outreach services
- Identify and evaluate strategic capabilities of infrastructure in Ireland
- Advise and signpost support on regulatory requirements
- Work closely with other MedTech supporting research organisations e.g Health Innovation Hub Ireland, HIHI
- Provide policy and benchmarking advice to key stakeholders
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-NCTO 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
