Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management
Cybersecurity breaches in healthcare continued at an alarming rate throughout the year, affecting operations and patient safety, while government agencies and policymakers focused on ways to improve resilience.
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing.