The ISO 14155:2020 (Clinical investigation of medical devices for human subjects – Good Clinical Practice) is the third edition of this standard of reference for the design, conduct, recording, and reporting of medical device clinical studies. It provides guidance to manufacturers and clinical research professionals on how to implement Good Clinical Practice (GCP) for pre and post-market clinical investigations designed to determine the safety and performance of a medical device. This session will focus on the new requirements introduced by the ISO 14155:2020, summarizing the differences with the prior version and putting in the context of the EU Medical Device Regulation (MDR 2017/745).
Maria Nyåkern is the President and CEO, leading the company to align the organization to its expansion in the medical device B2B sector. Dr Nyåkern founded AKRN Scientific Consulting in 2018 after working nearly 15 years in the regulatory and clinical development of medical devices technology at multiple medical device companies such as Cordis JnJ, Trivascular Inc, Medtronic and Abbott. Maria Nyåkern is a Doctor of Cell Biology at Stockholm University, Sweden (2003), and has completed a Postdoctoral Fellowship at the University of Bologna, Italy (2006). She is fluent in English, Spanish, Italian, French and Swedish.