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Key Takeaways
- Blue Goat Cyber will present critical FDA cybersecurity strategies at the AMDM 2025 Annual Meeting.
- Christian Espinosa will expose common cybersecurity pitfalls delaying the FDA submissions and outline avoidance tactics.
- The presentation will offer a three-step blueprint for integrating cybersecurity from the medical device design phase.
- Blue Goat Cyber's methodology helps manufacturers achieve successful the FDA clearances and accelerate time-to-market.
- This session is crucial for regulatory, quality, and engineering leaders in medical device manufacturing.
SCOTTSDALE, AZ, UNITED STATES, April 28, 2025 - Medical device manufacturers increasingly face regulatory setbacks, including cybersecurity deficiencies that can lead to FDA premarket submission delays and additional questions. At the 2025 Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting, Blue Goat Cyber will deliver essential strategies to help companies address these challenges and prepare more complete FDA submissions.
Christian Espinosa, Founder and CEO of Blue Goat Cyber, will present “Cybersecurity & Lessons Learned from CDRH FDA Software Reviewers” on April 30, 2025, at 3:20 PM Eastern Time in Bethesda, Maryland. His session will guide regulatory, quality, and engineering leaders through critical insights into what FDA reviewers expect, highlighting cybersecurity pitfalls that delay or derail submissions, and how to avoid them.