Blue Goat Cyber Named Gold Sponsor at MedTech World Malta 2025, Advancing FDA and EU MDR Cybersecurity Alignment

Blue Goat Cyber joins MedTech World Malta 2025 as Gold Sponsor, highlighting FDA & EU MDR cybersecurity compliance in MedTech.

VALLETTA, MALTA, November 6, 2025 /EINPresswire.com/ -- Blue Goat Cyber, a U.S.-based leader in medical device cybersecurity and global regulatory compliance, is proud to announce its role as a Gold Sponsor of MedTech World Malta 2025, taking place from November 12 to 14, 2025, at the Mediterranean Conference Centre in Valletta, Malta.

Blue Goat Cyber will exhibit at Booth G005, showcasing comprehensive cybersecurity and compliance services that help medical device manufacturers meet the evolving expectations of the FDA and the EU MDR for patient safety, resilience, and secure innovation.

Driving Global Cybersecurity Compliance for Medical Devices

Blue Goat Cyber partners with manufacturers worldwide to align cybersecurity risk management with regulatory frameworks, including the FDA’s 2025 Cybersecurity in Medical Devices Guidance, Section 524B of the FD&C Act, and the EU MDR/IVDR requirements for secure-by-design devices.
The company integrates ISO 14971, IEC 81001-5-1, and the Secure Product Development Framework (SPDF) to provide full-lifecycle support—from design control through postmarket surveillance.

“Cybersecurity is now inseparable from patient safety,” said Christian Espinosa, CEO and Founder of Blue Goat Cyber. “By bridging FDA and EU MDR requirements, we’re helping manufacturers innovate confidently while meeting regulators’ growing expectations.”

Blue Goat Cyber Leadership at Med-Tech World Malta 2025

Christian Espinosa — Panel: Navigating EU & US Regulations: Key Compliance Trends for MedTech
- November 13 | 09:50 – 10:25
- This panel examines the latest regulatory and cybersecurity developments influencing MedTech in the EU and the U.S., including the implementation of the MDR, FDA updates, and cross-border compliance strategies.
Panelists:
- Amra Racic, VP Global Government Strategy, Veeva Systems
- Edwin Lindsay, Managing Director, CS Lifescience
- Christian Espinosa, CEO, Blue Goat Cyber
- S. Oguz Savas, Head of Notified Body, Malta Conformity Assessment Inc.
- Ainoa Forteza, VP Regulatory Affairs Medtech, Alira Health

“Understanding how FDA and EU MDR interconnect gives MedTech companies a competitive advantage,” Espinosa added. “Compliance and security can, and should, accelerate innovation.”

Melissa Espinosa — Panel: Women in MedTech: Shaping the Future of Innovation & Leadership
- November 14 | 10:05 – 10:40
- This session highlights the influence of women leading innovation, inclusion, and mentorship in MedTech, with perspectives from global industry leaders.
Panelists:
- Khizra Ahmad, Director of Strategy & Leadership, APPSUK Foundation
- Katrina Laks, CEO, Migrevention
- Diana Saraceni, General Manager, Panakes Partners
- Melissa Espinosa, VP Strategic Partnerships, Blue Goat Cyber
- Claudia Preziosi, Head of Business Development and Operations, HepaTx

“Diverse leadership drives stronger, more innovative MedTech solutions,” said Melissa Espinosa. “I’m honored to be part of a panel amplifying that message.”

About Blue Goat Cyber

Blue Goat Cyber is a specialized cybersecurity consulting firm serving medical device, digital health, and connected care technology companies. Founded by Christian Espinosa, a recognized author and cybersecurity thought leader, the firm helps clients achieve and maintain compliance with FDA, EU MDR/IVDR, and Health Canada cybersecurity requirements through penetration testing, risk assessments, pre-market documentation, and post-market cybersecurity programs.

Learn more at https://bluegoatcyber.com
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About MedTech World Malta

MedTech World Malta is a leading international summit connecting MedTech innovators, investors, and regulators. The event explores breakthroughs in digital health, AI in medicine, regulatory alignment, and medical device cybersecurity, fostering collaboration to advance global healthcare innovation.

For more information, visit https://med-tech.world/malta
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Melissa Espinosa
Blue Goat Cyber
+1 844-939-4628
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