Weak cybersecurity strategies can cause submission delays, deficiency letters, and inconsistent global approvals.

This webcast will connect cybersecurity myths directly to real regulatory outcomes using global case studies. It emphasizes practical integration of standards and regulatory expectations rather than high-level or purely technical cybersecurity theory.

Attendees will learn how to align cybersecurity documentation with existing quality and risk management systems. The content provides clear guidance on how to support submissions, respond to regulator questions, and work effectively with engineering and quality teams.

From confusing data protection with patient safety to misunderstanding what qualifies as a cyber device, hosts will shed light on the blind spots that cause costly delays and compliance failures. They will also explore how medical device cybersecurity differs fundamentally from traditional cybersecurity, emphasizing the need for specialized expertise and early integration of secure design principles.

Member: $0|Nonmember: $50

Learning Objectives

• See cybersecurity through the lens of patient safety, not just data protection
• Recognize risks even in devices you think aren’t “cyber devices”
• Align with global regulatory expectations (FDA, EU MDR, IMDRF, APAC agencies)
• Build investor and partner confidence by showing you’re approval-ready worldwide

Who Should Attend?

Quality/regulatory affairs professionals in the medtech space, investors with a deep profile in medtech, medtech innovators building and scaling a product, and the engineers working on these products.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.