IVDeology Ltd was formed by Nancy and Stuart in 2018 based on the founding principle of providing practical quality and regulatory advice in a simple clear way to help business gain an awareness of the IVD regulatory environment.
Our aim is to develop and grow a small but successful team focusing on flexibility, personal development and gender equality. We believe that supporting our staff and helping them grow with us will benefit not only us, but also our customers.
Co-founder & Strategic IVDeologist
My career began working in NHS Pathology Laboratories and specialised in medical microbiology. From there I moved into the IVD industry as a Senior Technician trouble shooting and manufacturing IVD devices. I’ve worked in most areas of an IVD manufacturing company, managing departments until I moved into Quality and Regulatory Affairs. Having full oversight of the operations of an IVD manufacturer has placed me in an ideal situation to understand the design and development process from feasibility, to commercialisation and also retirement of a product and removal from market.
Co-founder & Solutions IVDeologist
I started my career in Remel which is now part of ThermoFisher Scientific manufacturing latex agglutination IVD tests. I progressed through ThermoFisher and moved into Regulatory Affairs, where I met Nancy. I followed Nancy over to Novartis Near Patient Testing where we CE marked an IVD product. In 2018 we created IVDeology Ltd.
We can provide technical support for verification and validation testing for Performance evaluation with strong expertise in Scientific validity and Clinical performance evaluation.
I have worked for major blue chip organisations in various roles and delivered successful cross functional projects at both local and global levels. Working from basic projects to complex projects such as delivering In Vitro Diagnostic Medical Devices (IVDs) through full lifecycle with CE marking.
I have expertise to deliver projects that will enable Quality Management System implementation and CE Marking of IVDs.
Starting in micro testing laboratories I then moved to an IVD manufacturing site working within a ISO13485 Quality Management System. I have a degree in Life Sciences, completed an ISO 13485:2016 internal audit course, and have worked across multiple departments working up to more senior roles gaining invaluable experience in IVD processes. I have always been heavily involved in training, raising and implementation of process changes, root cause investigation and approval of quality documents and batch records.
More recently I have been involved with implementing our internal EQMS to ISO9001:2015.