Lourda Killeen - Quality Systems Manager
Lourda current role in Versono Medical Ltd has overall responsibility for the introduction of a Quality Management System which meets the requirements of ISO 13485:2016,21CFR 820 and all governing Regulatory Standards. Having in excess of 20 years Quality Management experience within these Regulated Industries, Lourda has extensive knowledge and understanding of the Regulatory and Quality (GMP, cGMP) requirements relating to all aspects of the lifecycle of a sterile medical device including design, validations (design ,process ,sterilization etc), Regulatory Inspections and commercial distribution (including PRRC and post market surveillance responsibilities) cost reductions and product registrations to the relevant Regulatory Authorities – FDA, HPRA and various Notified Bodies.
