June 15 — Boston | June 22 — Silicon Valley
The need to harden cybersecurity is at an all time high. The FDA agrees. Recent (March 2023) regulations from the agency now require manufacturers to submit specific cybersecurity documentation with each 510(k) filing; without this, applications will be categorically rejected. The FDA also outlines the expectations for device manufacturers regarding cybersecurity throughout the product life cycle, including risk management, design controls and post-market surveillance. This half-day session is designed to help you better understand and comply with this new guidance, and propel you on your medical device cybersecurity journey. Register Now >>