ISO 14155 FDIS 2019 is in it’s final steps and has been carefully updated to allow harmonization with the MDR. Although MDR has taken a much more detailed approach both for ethical as well as study design requirements, thereby coming closer to the contents of the ISO 14155, the latter has been written to provide more in-depth guidance alongside the MDR requirements. Where MDR puts a greater emphasis on increased needs for clinical data generated through well designed prospective clinical investigations, ISO 14155 provides in depth guidance on how to develop the appropriate study design and which design is applicable in which stage of the life of a medical device both pre and post market. The presentation will cover the main changes in the new ISO 14155 while touching the gap analysis with the MDR.
With over 25 years of experience, Ms. Giroud is founder and Senior Faculty Board Member of the World Medical Device Organization (WMDO), an independent professional organization dedicated to serving the professional development and educational needs of medical device professionals. In 2013, she founded MD-CLINICALS -a 100% medical device full service dedicated CRO with main activities in the Asia Pacific region and Europe.
Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe. She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) task force.