Jane Leadsham
Jane Leadsham is a IVD Medical Device professional with 10 years experience gained working in in vitro diagnostic Medical device development firstly for Novartis Pharmaceuticals, and currently as a consultant regulatory medical writer. Jane specializes in supporting IVD manufacturers to meet the performance evaluation requirements of (EU) IVD Regulation 2017/746.
Jane has held several senior R&D scientist roles for both an in vitro diagnostic manufacturer and a biotech company and completed a five-year post-doctoral research project at the University of Kent. This cross-sector industry/academia experience has provided Jane with a thorough but diverse knowledge of research, development and product commercialization.
As a consultant medical writer to the IVD industry, under the (EU) IVD Regulations 2017/746, Jane has worked on end-to-end projects, including with Notified Bodies, and successfully completed CE certification of a Class C IVD device. Jane has completed performance evaluation documents for:
- three CDx devices including preparation of documents required for interventional performance evaluation studies,
- legacy devices transitioning from IVDD to IVDR, Classes A to D, and
- new devices in Classes A to C,
- complete sample to result fully automated systems, and
- near-patient testing/point of care device
Jane has also provided training programs on the performance evaluation requirements of the (EU) IVD Regulation 2017/746 to five device manufacturers. One manufacturer, with a complex, near-patient testing, Class D device, used Jane to provide template documents and regular on-going training and support for staff to complete the performance evaluation documents themselves. Further, Jane has acted as a third-party reviewer for performance evaluation documents written by external contractors, including AI.
As a Principal Scientist, and member of a near-patient testing device development team, with Novartis Pharmaceuticals, Jane led a group of scientists in conjunction with a CRO to design, develop and manufacture a key component of a cardiac marker immunoassay within the target timeline. Jane was part of the team that planned and executed a prospective clinical trial to assess the performance of the near-patient device .
