SFL publishes article on regulatory approval of software and digital healthcare devices
SFL’s Head of Combination Products Theresa Jeary, Head of Medical Devices Karin Schulze and Medical Affairs Manager David Restuccia have published the article “What medical writers need to know about regulatory approval of mobile health and digital healthcare devices in the EU and globally“ in Medical Writing, the journal of the European Medical Writers Association (EMWA). The article provides an overview of the current US and EU regulations governing software as a medical device/medical device software (SaMD/MDSW) and outlines how these have developed in response to the rapid growth of mobile health and digital healthcare. Further, the article provides key considerations in the preparation and submission of regulatory documents for SaMD/MDSW conformity assessment under the EU Medical Device Regulation (MDR), as well as regulatory approaches to developments on the horizon in technologies like artificial intelligence and machine learning.
SFL’s experienced medical device and combination products team can support your various MDR implementation projects by performing MDR gap analyses, proposing effective strategies to achieve MDR compliance and providing hands-on support with all aspects of MDR implementation to prepare your business against disruption when the new MDR/IVDR comes into full effect. Please contact us to discuss your projects.