Cybersecurity in Medical Devices – Practical Advice for FDA’s 510(k) Requirements
March 12, 2024 | 1 pm EDT
As the healthcare industry increasingly relies on interconnected medical devices, ensuring their cybersecurity is paramount to safeguard patient safety and data integrity. This webinar delves into the essential components of the FDA's requirements and provides practical guidance for implementing robust cybersecurity measures in connected medical devices.
The FDA's guidelines mandate that medical device manufacturers integrate cybersecurity into all stages of the product lifecycle, from design and development to post-market surveillance. This involves risk assessment, threat modeling, vulnerability management, and continuous monitoring to mitigate potential cyber threats effectively.
To comply with FDA regulations, manufacturers must adopt a risk-based approach tailored to the specific characteristics of their devices. This requires comprehensive understanding and analysis of potential vulnerabilities, including software flaws, network vulnerabilities, and human factors.
By attending you will receive practical advice for implementing cybersecurity in medical devices including:
- Secure product development framework (SPDF)
- Threat and risk assessments
- Validation and penetration testing
- Security architectures
Don’t miss this important webinar, which serves as a roadmap for medical device manufacturers to navigate the complex landscape of FDA requirements and implement effective cybersecurity measures.
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About The Presenters
Milton is the Director of Medical Programs for ICS. He is a certified PMP and Scrum Master with a background in software architecture, medical device product development and program management. He has 20 years in product development with 10 years in software consulting and 15 years working with Class II and Class III medical device manufacturers.
Colin is the founder and CEO of BG Networks. Before founding BG Networks in 2020, Colin worked at Analog Devices (ADI) for 29 years in various engineering, management, and marketing leadership roles managing teams located in U.S., China, Europe, and India. Colin’s experience includes work in automotive, consumer, industrial, and aerospace & defense markets.
Richard is Chief Strategy and Innovation Officer, Secure Platform at Trustonic. With over 30 years in the cybersecurity industry, he is a regular speaker and influencer on matters of cybersecurity. Prior to Trustonic, Richard spent 20 years at Citrix Mobility, leading projects ranging from embedded software to global enterprise systems, with a focus on user and developer experience.