Medical Device Embedded Security (FDA & ISO/IEC 81001-5-1 Aligned) Essentials Training by Tonex
This specialized 2-day training is designed to equip professionals working with medical embedded systems with the tools, knowledge, and regulatory insights necessary to build secure, compliant devices. Participants will explore secure firmware development, hardware-based trust anchors, and software bill of materials (SBOMs) in alignment with key standards including FDA Premarket Cybersecurity Guidance, AAMI TIR57, and ISO/IEC 81001-5-1. The course emphasizes the critical role of embedded security in protecting patient safety and securing connected healthcare environments. With cybersecurity threats escalating in healthcare, this program addresses how vulnerabilities in embedded components can pose risks and how to mitigate them through secure design and implementation.
Audience:
- Embedded systems engineers
- Medical device designers
- Cybersecurity professionals
- Quality assurance personnel
- Regulatory compliance officers
- Software engineers in medtech
Learning Objectives:
- Understand regulatory frameworks for medical device cybersecurity
- Identify embedded security threats in medical systems
- Apply secure coding practices for firmware development
- Leverage hardware trust anchors and cryptographic components
- Build and manage SBOMs aligned with FDA and ISO/IEC guidelines
- Develop embedded system security risk assessments and mitigation strategies
Course Modules:
Module 1: Medical Device Cybersecurity Landscape
- Overview of connected medical device threats
- Role of cybersecurity in patient safety
- Key vulnerabilities in embedded systems
- Regulatory drivers and compliance trends
- Stakeholder responsibilities in securing devices
- Case studies: security failures in medical devices
Module 2: Regulatory Standards and Frameworks
- FDA Premarket Cybersecurity Guidance
- AAMI TIR57 principles and practices
- ISO/IEC 81001-5-1 security requirements
- Mapping between standards for compliance
- Roles of IEC 62304 and 60601 in security
- Preparing for regulatory audits and reviews
Module 3: Secure Firmware Development
- Secure coding best practices for C/C++
- Input validation and memory safety
- Code signing and firmware verification
- Managing third-party and open-source code
- Secure boot processes and lifecycle controls
- Version control and secure release procedures
Module 4: Hardware Trust Anchors
- Introduction to root-of-trust concepts
- TPM, PUFs, and secure elements overview
- Leveraging HSMs in medical device design
- Hardware key storage and cryptographic protections
- Boot process integrity with trust anchors
- Integrating secure hardware with firmware
Module 5: SBOM and Supply Chain Integrity
- SBOM creation and format standards (e.g., SPDX)
- FDA expectations for SBOM documentation
- Dependency tracking and vulnerability management
- Supply chain risk assessment methods
- Handling third-party software disclosures
- Continuous monitoring of SBOM health
Module 6: Risk Management and Mitigation
- Threat modeling for embedded medical systems
- Risk scoring methods (e.g., CVSS)
- Building and validating a cybersecurity risk file
- Defense-in-depth for embedded security
- Incident response and postmarket controls
- Aligning risk strategies with ISO/IEC 81001-5-1
Join Tonex’s Medical Device Embedded Security Essentials Training to gain hands-on, regulation-aligned knowledge and tools for securing medical device firmware and hardware systems. Stay compliant, reduce cyber risks, and protect patient safety with confidence. Secure your spot today!