ARTICLE SUMMARY:
How MDR impacts the day-to-day decision-making of medtech CEOs and investors that run and fund start-ups in Europe; Kevin Fu's in-depth update on what companies need to do to protect legacy devices and new products from cyber threats; tips from MCRA's Tim Marjenin on making a "least burdensome" case to FDA; redesigning FDA premarket review; and the EU prepares to launch a dashboard of notified body performance metrics.
