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
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.
Certificate of Participation available upon request for live attendees.
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