Neasa and I met at a medical device conference in Dublin in late 2012. When I learnt that she had expertise in complaint handling and vigilance-related reporting to Competent Authorities, I asked whether she could support a Sedana Medical quality system improvement initiative. Within weeks of our initial meeting, Neasa flew to Sweden with our quality team to focus on the complaint handling improvement plan. That was our first engagement and we have continued to work together since. Neasa is the internal auditor for our company and has worked on a number of subsequent targeted quality system improvement initiatives including: risk management, CAPA and new product development.
Over the years, Neasa has provided quality and regulatory guidance and support as Sedana Medical has expanded its medical device product line and market share. Our company is committed to excellence and I know that Neasa shares this same dedication to quality. No matter how urgent or complex the situation is, she always finds a way to steer us in the right direction. She ensures the best possible outcome for our customers and business through collaboration with our quality team. I can rely on Neasa’s expertise to direct us and ensure regulatory compliance in all our endeavours.
Based on my ongoing professional relationship with Neasa, I highly recommend her as a quality system and medical device Subject Matter Expert. She is a reliable consultant that will guide any organisation towards success in the medical device industry.Sedana Medical, Chief Operating Officer – Operations / R&D / Quality