Mary Ryan, Director of Innovation, Technology & Regulatory Affairs, Penlon
Mary Ryan is Director of Innovation, Technology and Regulatory Affairs at Penlon Ltd, responsible for delivering the strategic, quality, and technical requirements in the development of anaesthesia and respiratory-care medical devices for global markets. With almost 30 years in quality assurance and regulatory affairs, Mary champions efforts to bring a more modern technology outlook to Penlon's product vision and is driving initiatives in the area of creating and levering new technology solutions and clinical partnerships.
Mary started her engineering discipline within plastic injection moulding and electronics manufacturing. From there, Mary has led a number of prominent projects including contribution to vocational educational programs, developing certification programs for Dental and Cosmetics industries, led multi-million-dollar medical device outsourcing projects and in more recent times, as PRRC, Development and Regulatory Lead for the NHS Ventilator Challenge.
From 2007-2011, Mary headed up a UK Notified Body and made noteworthy contributions in influencing positive changes in global medical device regulations; from 2008, participating with 3 other EU Notified Bodies as a consortium in the redevelopment of Kingdom of Saudi Arabia FDA (KSFDA) medical device legislation, working directly with the Israeli-Palestinian Chamber of Commerce and Health Ministries on CAB imports and more recently in UK, with the MHRA and ABHI to update policy for Virtual Manufacturing under EU MDR and as a key Industry contributor for UK MDR.
Mary holds a Bachelor of Science (Hons) in Quality Management; incl French and Commerce from Heriot Watt University and is an active participant of the ABHI Technical Policy group.