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Cybersecurity in Medical Devices – Practical Advice for FDA’s 510(k) Requirements

Tuesday, March 12, 2024 (1:00 PM - 2:00 PM) (EDT)


As the healthcare industry increasingly relies on interconnected medical devices, ensuring their cybersecurity is paramount to safeguard patient safety and data integrity. This webinar delves into the essential components of the FDA's requirements and provides practical guidance for implementing robust cybersecurity measures in connected medical devices. 

The FDA's guidelines mandate that medical device manufacturers integrate cybersecurity into all stages of the product lifecycle, from design and development to post-market surveillance. This involves risk assessment, threat modeling, vulnerability management, and continuous monitoring to mitigate potential cyber threats effectively. 

To comply with FDA regulations, manufacturers must adopt a risk-based approach tailored to the specific characteristics of their devices. This requires comprehensive understanding and analysis of potential vulnerabilities, including software flaws, network vulnerabilities, and human factors. 

By attending you will receive practical advice for implementing cybersecurity in medical devices including: 

  • Secure product development framework (SPDF) 
  • Threat and risk assessments 
  • Validation and penetration testing 
  • Security architectures 

Don’t miss this important webinar, which serves as a roadmap for medical device manufacturers to navigate the complex landscape of FDA requirements and implement effective cybersecurity measures.

Register Now

Tuesday, March 12, 2024 (1:00 PM - 2:00 PM) (EDT)
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