A recent survey found that 66% of healthcare organizations were hit by ransomware last year, up from 34% in 2020, and that healthcare had the highest increase in the volume of cyber-attacks among all sectors, at 69% year over year. This session will focus on the latest news and updates concerning cybersecurity in relation to medical devices and the changes in equipment evaluation processes. The presenters will discuss the safeguards that have been added during implementations and what organizations are doing to prepare for potential attacks.

Learning Objectives:

1. Define how medical device manufacturers will need to ‘think like regulators” when considering their product lifecycles.

2. Explain what the FDA expects from manufacturers in terms of quality management systems to counteract cybersecurity issues.

3. Apply the FDA’s final guidance providing recommendations to the industry regarding cybersecurity device design, labeling, and documentation.

4. Identify the necessary elements of an effective and updated cybersecurity plan

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