Orla Connaughton
Orla Connaughton, CEO, Aztec Medical
Orla Connaughton, B. Mech Eng., MPM, PMP is a regulatory affairs professional who established Aztec Medical Ltd. to provide regulatory, clinical, design assurance and quality management support to the MedTech industry. Her mission is to provide strategic and practical advice to clients to ensure that medical technologies receive regulatory approvals as efficiently as possible to improve the lives of patients and clinicians globally.
Orla obtained a Bachelor of Mechanical Engineering Degree from the University of Galway, Ireland and Masters in Project Management from the University of Limerick, Ireland. She was awarded Project Management Professional certification from the Project Management Institute, Dayton, Ohio, USA.
Orla has held senior management positions for both multi-national organisations and start-up organisations and has a regulatory and clinical consulting company for over 15 years. She has worked through all phases of the product development lifecycle from concept to commercialisation to retirement.
Through her career, she has held positions in research and development, manufacturing, project management, quality and regulatory. She works with all class of medical devices, primarily in the following clinical areas; vascular, gastrointestinal, cardiology and general surgery. She has authored a number of learning modules for masters’ programmes and is guest lecturer on a number of business and medical device masters programmes in Irish Universities. She presents at medical and pharmaceutical conferences on various topics of interest to the MedTech sector.
Aztec Medical provides regulatory, clinical, design assurance and quality management expertise for new product developments and existing commercial devices in all geographic regions; Europe, USA, Canada, Australia, Latin America and Asia. They provide pre- and post-market services such as safety reporting, post-market report services, design assurance activities, PRRC responsibilities, generation of Technical Documentation and implementation of quality management systems including training on relevant aspects such as ISO13485, ISO14971, MDR 2017/745 etc.