Medical Device Cybersecurity Risk Management Training

Why Should You Attend:

You should attend this webinar to understand the regulatory requirements for cybersecurity and its risk management.

Learning Objectives:

• Describe the terminology and definitions related to medical device cybersecurity
• Identify the requirements for cybersecurity by design, including relevant standards, adversarial resilience analysis, remote access control, supply chain rigor, and requirements for premarket submissions in US and EU.
• Describe a proactive, risk-based approach in third-party collaboration, integrating cybersecurity-specific post market requirements, and working with researchers and organizations to identify emerging vulnerabilities and threats.
• Describe best practices for evidence capture during safety investigations that are independently reviewable, preserve information about the event (including chain of custody and tamper resistance) while avoiding privacy and surveillance concerns, and provide a mechanism for reapplication of knowledge.
• Identify mechanisms for resilience and containment, including minimizing exposures, creating secure environments for isolation and segmentation, creating visible and safe modes of failure, while preserving data integrity.
• Describe strategies for rapid, efficient cyber safety updates, such as automation and process documentation, secure update processes, stakeholder communication (including FDA), and OTS update verifications.

Areas Covered in the Webinar:

• What is cybersecurity for medical devices?
• What kind of products are affected?
• How to apply risk management for medical device?s cybersecurity?

Frequently Asked Questions:

1. What is a key to starting a successful medical device security program?
2. Why Should one use a 3rd party for CYBER SECURITY ASSESSMENT?
3. How does cybersecurity affect the choice of medical devices?
4. What are the top priorities for a new medical device security program?

Who Will Benefit:

• R&D Manager
• Regulatory Affairs Manager
• Product Manager

From Medical Device Manufacturing companies that manufacture electronical medical devices with software components

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

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