Angela O Sullivan
Angela has successfully managed the implementation and certification of ISO 13485 in several Irish medical device start-up companies. With many years’ experience in quality management systems, in 2009 Angela started to focus almost exclusively on the medical device sector. Her aim is to develop a tailored solution for each client so that they are adequately supported to meet their commercial timelines. Once the quality management system is in place and certified, Angela supports the client in hiring a permanent resource to manage the quality system, thus ensuring continuity.
Aine joined Arwen Consulting in 2013 in order to support activities such as document compliance, procedure review, document change control and file preparation. While Aine has only recently started working in the medical device sector, she has worked in a senior capacity in regulated environment for several years. She is accustomed to working to strict standards and tight deadlines, while achieving the highest level of compliance and therefore was able to easily transfer those skills in order to support the demands of ISO 13485 quality management systems.
Marie Rooney is an independent regulatory consultant in Medical Device and Diagnostic areas with a track record of success in both EU and FDA regulatory environments from concept through to commercialisation e.g ISO System design and implementation, design control systems implementation, sterilisation validation, CE marking, Technical file preparation, literary reviews for clinical evaluations etc.
Marie has 20 years’ general management experience in the healthcare industry with particular experience in diagnostics. Ms Rooney was Operations Manager with Trinity Biotech Plc, an Irish headquartered diagnostics company. Previously, Marie was an R&D scientist with Cambridge Diagnostics Ltd., a wholly owned subsidiary of Inverness Medical Innovations Inc. Marie is a graduate of the University of Limerick and holds a Masters degree in Project Management.
RD & I Management Professional
Jenny Patterson is an RD&I Management Professional with 20 years’ experience of setting-up and developing national and international research activities in both academic and industrial environments. Jenny is the Manager (Acting) of PrimeUCC – a project management service for Horizon 2020 proposals and projects – and has been working with the Office of the Vice President for Research and Innovation (OVPRI) Research Support Services in UCC for several months to develop, win approval for, and launch the enterprise.
Jenny has been involved in EU Framework Programmes since FP3 and has been engaged in various roles in 12 successful projects to date. In 2009, Jenny set-up her business “Cygnus Solutions” in order to offer solutions to RD&I focused clients on all aspects of Research, Development and Innovation (RD&I) management. This business succeeded in winning business from a variety of clients including an Irish indigenous start-up (medical device sector), three world-renowned research centres (focused on nanotechnology, ICT, and sensors), a university requiring commercial technology transfer in biotech and food, and a semiconductor multinational focused in electronics design.