Episode description
Episode description
This panel was recorded 12 December 2024. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.
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As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.
Join our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.
Our panel of industry experts will provide clear, implementable guidance on:
- Practical strategies for meeting EU MDR and US FDA cybersecurity requirements - with real-world examples and documentation approaches
- Essential security considerations for medical devices, IVDs and SaMD development
- How to integrate cybersecurity requirements into your quality management system from the start
- Standards for risk management, pre- and post-market considerations that satisfy both regulatory requirements and long-term security objectives
- Strategic planning for maintaining security throughout your product lifecycle
- Common pitfalls to avoid in cybersecurity implementation and regulatory submissions
- The role of SBOMs (Software Bills of Materials) in achieving transparency and regulatory compliance
Who Should Attend: This session is essential for medical device manufacturers, software developers, quality professionals, and regulatory teams working with connected devices or SaMD. Whether you're bringing your first connected device to market or optimizing your current cybersecurity approach, you'll gain practical insights for ensuring both compliance and security.
Panelists:
- Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation, RQM+
- Mirko Raner – Cybersecurity Consultant, RQM+
- Hrishikesh Gadagkar – Senior Principal, RQM+
Moderator:
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+
Listen to gain practical insights that will help you navigate the evolving cybersecurity landscape with confidence, backed by RQM+'s extensive experience in medical device regulatory compliance and software validation.
Chapters
00:00 Introduction to Medical Device Cybersecurity
03:17 Understanding Cybersecurity in MedTech
08:14 Defining Cyber Devices and Regulatory Requirements
14:39 Translating Regulatory Guidance into Practical Strategies
22:57 Addressing Audience Questions on Cybersecurity
29:43 Understanding Near Field Communication in Medical Devices
30:44 Navigating Threat Actors in Cybersecurity
31:43 FDA Review Process for Cybersecurity
32:40 Common Deficiencies in Cybersecurity Submissions
34:03 Critical Gaps in Cybersecurity Documentation
37:19 Essential Security Considerations in Device Design
40:00 Integrating Cybersecurity into Development Processes
43:16 Real-World Examples of Cybersecurity in QMS
45:57 Shared Responsibility for Cybersecurity in Healthcare
48:27 Best Practices for Cybersecurity in Medical Devices
51:24 Automating Cybersecurity Vulnerability Assessments
54:58 Exploitability vs. Probability in Risk Management
57:48 Operationalizing Cybersecurity Standards in Development
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