I have worked with Neasa for a number of years. I truly value her contribution and do not hesitate to recommend her as a medical device QA/RA consultant. Neasa became my direct report during my time as interim Director of Quality Systems in Asia Pacific for Boston Scientific.
I find her to be exceptionally knowledgeable about the regulations and quality system requirements whilst also maintaining the flexibility to find practical solutions that work for country and region-specific scenarios and allow for positive and compliant outcomes in our agile business environment. She is focused on the fine details of solutions whilst still maintaining overall control of the big picture.
We work well together and I feel confident assigning work to her as I know it will be completed to my own high personal standard. She is calm under pressure and takes every challenge in her stride. She builds and maintains strong relationships across the various project teams she interacts with. I believe it is important for a consultant to add value to an organisation and I think that Boston Scientific has achieved this through its ongoing engagement of Neasa as a Quality System Consultant.
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.
I began working with Neasa as a Consultant in November 2014 as Cosmo Pharmaceuticals was preparing to develop an ISO 13485 / CFR 21 Part 820 Quality Management System in order to support the design, manufacture, marketing approval and distribution of medical device products. Cosmo needed a Quality and Regulatory expert within the medical device industry to develop the QMS, train Cosmo staff on the requirements and regulations and support the submission of our devices for 510(k) and CE Mark approval.
Over the course of our working relationship, Neasa has been our regulatory and quality Subject Matter Expert in relation to Medical Devices in particular, and the QMS in general. She supported Cosmo extensively in the building and improvement of the QMS and works with our quality team to continuously improve it and ensure its effective implementation. She is also our lead auditor who is responsible for the execution of our internal audit program and she conducts all our supplier quality audits, including on-site audits of critical suppliers. In 2018 we joined the MDSAP audit program.
Neasa worked alongside the Cosmo quality team to upgrade the QMS to ensure audit-readiness. Her support was invaluable in achieving a successful MDSAP audit outcome. Neasa works well with our quality team, suppliers and external Notified Bodies and I know I can rely on her to support us when urgent matters arise. I highly recommend Neasa as a Quality and Regulatory expert. She has a highly professional approach, a great level of knowledge and a practical approach to problem solving and is a pleasure to work with.
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.
I began working with Neasa in November 2017 as Design Partners were investigating some changes to our Quality Management System. She supported us to update our Quality Manual to comply with the 2016 revision of the ISO 13485 standard.
Neasa worked with our Healthcare and Science team to brainstorm our annual 2018 quality objectives and provided guidance on how to set realistic quality KPIs that would help us to drive improvement and efficiencies. She drafted a number of new procedures and supported what we call a “Quality System Re-Set”.
We continue to work together as Neasa is our internal auditor lead and supports us with medical device regulation and industry trend training. Based on my experience, I consider her to be an expert in medical device standards and requirements who is able to find company-specific solutions to ensure compliance. I have no hesitation to recommend Neasa as a quality and regulatory consultant for any company working in the medical device innovation sector.
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If you are a medical device innovator who demands excellence, then contact Neasa Greene Consulting today for an initial consultation.