Medical Device Cybersecurity and FDA Readiness Course

Connected medical devices are transforming healthcare, but they also introduce significant cybersecurity risks. Manufacturers now need to demonstrate robust security practices to satisfy FDA expectations and maintain audit-ready documentation.

This short, practical course from Akitra Academy teaches medtech teams how to build secure, resilient devices while aligning with regulatory requirements and operational cybersecurity workflows. Learners will gain actionable guidance for designing secure architectures, managing software components, handling vulnerabilities, and preparing documentation that supports audits and customer reviews.

What You’ll Learn

By the end of this course, you will be able to:

• Understand the Medical Device Cybersecurity Lifecycle: Learn how cybersecurity impacts patient safety, regulatory compliance, and device performance, and how to integrate it across the entire lifecycle.
• Perform Threat Modeling and Secure Architecture Design: Identify risks, assess attack surfaces, and implement secure-by-design principles for connected and embedded medical devices.
• Manage SBOM and Supply Chain Security: Maintain visibility into software components, track vulnerabilities, and handle open-source and third-party risks effectively.
• Implement Vulnerability Management and Coordinated Disclosure: Establish structured processes for identifying, prioritizing, patching, and disclosing vulnerabilities to ensure postmarket security readiness.
• Prepare Audit-Ready Documentation: Create traceable, review-friendly artifacts linking risks, controls, testing, and evidence to streamline FDA and customer audits.

Who This Course Is For

This course is ideal for professionals in medical device organizations, including:

• Medtech product teams
• Regulatory affairs professionals
• Engineering and software development teams
• Quality and compliance teams
• Security leaders and risk management teams
• Anyone responsible for connected medical devices and cybersecurity readiness

Frequently Asked Questions