Sue leads Qserve’s IVD service, she has over 30 years’ experience in the Medical Deviceand IVD industries including extensive notified body experience.Key areas of expertise include
• IVDD and IVDR regulations
• QMS implementation
• Internal, supplier and compliance audits
• Risk Management
• Working with small start-up and multinationals
Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing and quality assurance. Sue worked for 3 notified bodies establishing two from scratch. Sue chaired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years.Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands on experience with the requirements.