Episode description

⁠This panel was recorded 30 January 2025.⁠⁠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.

As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.

Join part two of 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+

Register now 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.

Part one is available on demand here.

Chapters

00:00 Introduction to Medical Device Cybersecurity

03:21 Navigating FDA Regulations and Cybersecurity

11:38 Effective Documentation Frameworks for Cybersecurity

15:47 Understanding Medical Device Data Systems (MDDS)

24:12 Cybersecurity Challenges for In Vitro Diagnostic (IVD) Devices

27:02 Addressing Cybersecurity in Interconnected Devices

32:41 Risk Assessment and Cybersecurity Documentation

37:12 Understanding FDA Regulations for Medical Devices

40:54 Cybersecurity Considerations in Medical Devices

42:00 Assessing Cybersecurity Threats and Vulnerabilities

49:02 The Role of Risk Analysis in Cybersecurity Documentation

56:46 Integrating Cybersecurity and Safety Risk Assessments

01:09:53 Future-Proofing Against Cyber Threats

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