RQM+Live_86_On_Demand

While this session will definitely provide value on its own, we encourage you to watch part one on demand before joining this panel discussion.

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.

Certificate of Participation available upon request for live attendees.

Watch the Recording ▶️