Published:
Key Takeaways
- Blue Goat Cyber is launching into the Asian market at the Mednovation Forum in Shanghai.
- This expansion focuses on helping Asian MedTech manufacturers meet global cybersecurity standards.
- Blue Goat Cyber will specifically support manufacturers in achieving the FDA clearance for their devices.
- They will present their Total Product Life Cycle approach to cybersecurity at the forum.
- Blue Goat Cyber aims to assist China's growing medical device industry with critical cybersecurity services.
- Cybersecurity Risk Management: Assisting manufacturers in identifying and mitigating cybersecurity risks in compliance with FDA guidance and ISO 14971 standards.
- Threat Modeling and Security Design: Developing threat models using frameworks like STRIDE to identify potential security risks throughout the device lifecycle.
- Premarket Submission Support: Guiding manufacturers through the FDA’s premarket submission process, including the use of eSTAR templates for 510(k) submissions.
- Postmarket Surveillance: Creating robust postmarket surveillance plans for ongoing compliance and rapid response to new threats.
SCOTTSDALE, AZ, UNITED STATES, October 24, 2024
Blue Goat Cyber, a leader in medical device cybersecurity, is excited to announce its participation in the Mednovation International MedTech Forum in Shanghai, China, on November 4-5, 2024.
This strategic engagement marks a significant step in Blue Goat Cyber’s global expansion, focusing on providing cybersecurity solutions to Asian medical device manufacturers, with an emphasis on FDA clearance support.