Jordan John

Bringing a medical device to market is challenging enough; navigating the ever-evolving landscape of regulatory cybersecurity requirements adds another layer of complexity. This session will provide medical device and MedTech companies with the knowledge and strategies needed to ensure their devices are both secure and compliant, minimizing costly delays and submission rejections. With the FDA now mandating cybersecurity testing and documentation, failure to comply can result in regulatory and market setbacks. This session will cover how manufacturers can align their cybersecurity strategies with FDA expectations to eliminate roadblocks, prevent rejections, and secure faster clearances and approvals. Key Takeaways: · How to integrate cybersecurity compliance seamlessly into your regulatory strategy · Understanding FDA’s cybersecurity expectations and the five-phase framework for success · The role of penetration testing, threat modeling, and SBOM management in compliance · How to turn cybersecurity into a competitive advantage for investors, regulators, and partners