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Digital Regulatory / Clinical

Digital Clinical & Regulatory Compliance and Workstream
  • Digital Health Regulations & Clinical Workstream – A panel of cross-functional experts e.g. (Academic, National Regulatory, Consultants, Industry Experts, Standards, and Key Opinion Leaders) to support the ecosystem on critical digital health regulation and clinical compliance:

    • Software as a medical device (SaMD)

    • Digital therapeutics Software

    • Electronics & Smart Devices

    • Systems Engineering  - Model-Based System Engineering [MBSE]

  • Quality Management Systems – ISO 13485: 2016 – Medical Devices Regulation Changes CE / MDR & FDA.

  • Device Classification & Regulatory Pathway – Expertise Shortlist - Digital Health Consultants Register.

  • Skills / Education future digital health needs for clinical and regulatory compliance.

  • Academic Collaboration / Identity and partner expertise.

  • Notified Body – National Standards Authority of Ireland / Competent Authority (CA) – Health Products Regulatory Authority

    • ​The Cluster is a member of the National Standards Authority of Ireland, TC21 NSAI: Health Informatics Standards Committee (HISC Digital Health Standards).


  • Other information and valuable links. Resources Links Webinars / Physical Events.

  • Digital Clinical & Regulatory Showcase / mini-conference.

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Partnership & Alliances

The Digital Health Industries Cluster is evaluating the various Science Foundation Ireland Research Centres, Academic and Commercial Research Centres, Technology Gateways, and digital health expertise, in the Irish Digital Health Ecosystem.  The cluster is open to collaborating on behalf of all its LifeSciences and Healthcare members to collaborate and innovate in this space.

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