Neasa and I connected in the summer of 2016 based on a recommendation from my colleague, Fiona Manning. I was looking for a medical device quality and regulatory expert to support a planned Class III medical device clinical trial. The intent of engaging a consultant was to ensure that all activities related to the clinical investigation including training, documentation, supplier auditing etc. were conducted as per the medical device regulations and standards; whilst adhering to Good Clinical Practice and ISO 14155. Neasa delivered training and a medical device clinical investigation workshop on-site at RCSI. She also attended our Education and Research Building at Beaumont Hospital to collaborate with our Quality and Regulatory Affairs Manager on preparations for the trial.
After this successful engagement, I have continued to work with Neasa as part of a national Initiative called Corporate Enabling of Clinical Research, involving Irish academic Institutions, CRDI, Cancer Trial Ireland, HRB, SFI and EI. Neasa provides medical device expertise related to our governance planning to ensure that all medical device clinical trials are conducted in compliance to regulations, standards and requirements. The initiative is managed by the Clinical Research Development in Ireland organisation. She was invited to attend our first Corporate Enabling of Clinical Research Conference in May 2018 and will continue to support the strategic plan associated with medical device clinical trial governance.
I consider Neasa to be an expert in her field who works well with cross-functional teams and suppliers. She ensures that all her activities are completed to the highest standard and has the skill to break down the complexity of the medical device requirements into manageable step by step activities. I am delighted to recommend her as a medical device quality and regulatory consultant.RCSI, Associate Director of Research