Head of IVD, EU Regulatory & Quality Expert
Sue leads Qserve’s IVD service, is EU Regulatory and Quality Expert including CDx and Lead Auditor.She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience
Sue has worked for several IVD companies ranging from start ups 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.
The key expertise areas of Sue:
- Notified Bodies: Sue has extensive notified body experience, working at a senior level in three medical device and IVD notified bodies spanning 20 years.
- Detailed knowledge of the IVD Regulation: During her time with the Notified Bodies, she was responsible for setting up two IVD Notified Bodies and chaired the IVD working group which was part of the NB-MED and attended the Commissions IVD Technical Group on behalf of the Notified Bodies. This group is responsible for creating guidance documents to the regulations.
- Quality management system set up and improvement: In addition to her Notified Body experience Sue has a total 30 years’ experience in the IVD industry working for companies ranging from small start ups to large multi-nationals. During this time, she has been responsible for creating and implementing completely new quality systems as well as simplifying complex multi-site systems to be compliant with both European and US requirements.
- Expert advice: Sue has also worked as a consultant during the implementation of the IVD Directive and is experienced with implementing the new requirements, gaining CE marking using a notified body, resolving complex borderline issues and readiness audits.
- Training: Sue is an experienced trainer running training and especially interactive workshops in the regulations and various aspects of the quality management system.
Learn more about our services within IVDR Compliance and Services