Lisa Donlon
Quality & Regulatory Lead at Vertigenius
Based in Ireland
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Seniority
Manager
Department
Other
Location
Ireland
Industry
Wellness and Fitness Services
Company size
12
Contact information
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l•••••••@vertigenius.com
Phone
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Background
About Lisa Donlon
Lead Consultant and Director at Donlon Life Science Consulting Ltd. Specialising in consulting in the area of market access for the medical device industry. Start-up and innovation focused. De-risking for investment. EU specialist. General business consulting on quality management system (QMS) planning, implementation and remediation. IRCA accredited principal auditor. Medical device specific consulting in the areas of- clinical strategy and CEP/CER review and remediation - regulatory submission compilation and support- post market surveillance activity support- standard/regulatory gap assessments- audit readiness & supplier audits- CAPA system remediation Previously European Operations Manager for NSAI Medical Devices. Joint head of the Medical Devices Notified Body designated under MDD/AIMD/IVDD/MDR and IVDR. File manager and product reviewer for active non-implantable devices, non-active cardiovascular and soft tissue implants, and general non-active non-implantable medical devices. Notified Body regulatory and non-regulatory lead auditor.
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