The RSRC has a strong record of collaboration with various groups within the International Standards Community.
Members of the Regulated Software Research Centre serve as authors, editors and International Project Leaders on a number of technical reports. These technical reports focus on medical IT networks and medical device software development lifecycle processes and into trustworthy and ethical AI development. A list of technical reports is provided below:
- IEC/TR 80002-3:2014 Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Project Leader: Dr Fergal McCaffery - ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
Project Leader: Dr Silvana Togneri MacMahon - IEC/DTR 80001-2-8 Application of risk management for IT-networks incorporating medical devices -- Part 2-8: Application guidance -- Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
Project Leader : Anita Finnegan - IEC/NP TR 80001-2-9 Application of risk management for IT-networks incorporating medical devices -- Part 2-9: Application guidance -- Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
Project Leader: Anita Finnegan - IEC 80001-1:2010 Revision Application of risk management for IT-networks incorporating medical devices - - Part 1: Roles, Responsibilities and Activities - Approach to the revision and Process Aspects
Project Leader: Dr Silvana Togneri MacMahon (Comment Resolution on CD Draft - Scheduled for publication 2020) - IEEE P7003 - Algorithmic Bias Considerations
Project Leader: Dr Róisín Loughran
