Digital Regulatory / Clinical

Digital Clinical & Regulatory Compliance and Workstream

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• 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]

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

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• 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.

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• 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).

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

• Digital Clinical & Regulatory Showcase / mini-conference.