Niamh S.

MedTech Expert, Software and AI

Galway, County Galway, Ireland

About

30 Years' experience in IT, Pharmaceutical and Medical Device industries within UK, Switzerland and Ireland. Highly educated and motivated. Expert in Medical Device Regulations, QMS, Risk Management, SaMD and AI

Experience

  • PhD Researcher of AI-enabled Medical Devices, Regs and Standards, & P/T Lecturer Software Validation at Dundalk Institute of Technology

    AI-enabled Medical Device; Standards Development in Software (IEC 62304 Ed2) AI (IEC 63450) with IEC and ISO Technical Committees on behalf of Ireland and NSAI

  • Founder, MedTech Expert at St John Lynch & Co.

  • Director QA/RA at SymPhysis Medical

  • Regulatory Affairs Manager at Veryan Medical

  • QA/RA Consultant at SymPhysis Medical

  • Founder at St John Lynch & Co.

    Regulatory AI Software Engineering and Regulatory Services to the MedTech Industry.

  • Senior Design Assurance Manager at Veryan Medical

  • Director of Regulatory Affairs and Quality at Caldera Medical

    Regulatory Software Cybersecurity 510k