On July 12, 2019, the following new EU directive and regulation on cross-border distribution were published in the Official Journal of the European Union...more
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more