Certified Medical Device Cybersecurity Specialist (CMDCS) Professional Certification by Tonex / NLL.ai
The Certified Medical Device Cybersecurity Specialist (CMDCS) certification is a rigorous, practitioner-level program designed for engineers, security professionals, auditors, and regulatory leaders responsible for ensuring the cybersecurity of medical devices across their entire lifecycle.
The certification aligns with and integrates global standards and regulations including:
- FDA Pre-market Cybersecurity Guidance (2023)
- FDA Postmarket Management of Cybersecurity in Medical Devices
- AAMI TIR97:2019
- AAMI SW96:2023 (Security Risk Management)
- AAMI SW91 (Classification of Defects)
- ISO 14971:2019 (Risk Management)
- IEC 62304 & IEC 81001-5-1 (Health Software Security)
- NIST 800-53 & NIST 800-82 for healthcare environments
The CMDCS teaches the end-to-end processes needed to design, test, certify, deploy, and maintain secure medical devices—covering embedded systems, networked devices, cloud-connected devices, IoMT platforms, and hospital environments.
Learning Objectives
Participants will be able to:
- Cybersecurity & Threat Analysis
- Identify and evaluate cybersecurity risks unique to medical devices and healthcare environments.
- Apply threat modeling frameworks (STRIDE, STPA-Sec, DREAD, PASTA).
Secure Design & Architecture
- Implement security-by-design concepts for embedded, wireless, cloud-connected, and IoMT devices.
- Apply SW96:2023 and TIR97 postmarket security risk management.
Secure Development
- Integrate secure SDLC into medical device development under IEC 62304 & FDA expectations.
- Apply vulnerability management, patching strategies, SBOM security, and secure coding guidelines.
Regulations & Compliance
- Map device cybersecurity requirements to FDA submissions:
- Cybersecurity Bill of Materials (CBOM)
- Threat modeling artifacts
- Security Risk Management Report
- Secure update mechanisms
- Testing & penetration testing evidence
Testing & Validation
- Conduct cybersecurity verification & validation (V&V).
- Perform penetration testing, fuzzing, and secure interface testing.
Deployment & Monitoring
- Build secure operational models including log monitoring, anomaly detection, and incident response.
- Apply TIR97 postmarket actions and coordinated vulnerability disclosure (CVD).
Target Audience
- Medical device engineers
- Embedded system engineers
- Cybersecurity engineers & analysts
- Regulatory affairs specialists
- QA/RA engineers
- Software developers
- Product security officers
- Healthcare IT security professionals
- System integrators & cybersecurity auditors
Prerequisites
Recommended (not required):
- Basic cybersecurity knowledge
- Understanding of medical device lifecycle
- Familiarity with risk management (ISO 14971)
- Basic embedded systems or software engineering knowledge
Course Length
2 days (Intensive Certification Course)
Optionally delivered as 3-day version with additional labs & exam prep.
Program Modules (Detailed)
DAY 1 — Foundations, Risk, Architecture, and Secure Development
Module 1 — Medical Device Cybersecurity Fundamentals
- Medical device ecosystem (embedded, networked, cloud, mobile apps, IoMT)
- OT + IT + Safety crossover
- Cyber-physical risks in healthcare
- Differences between traditional cybersecurity and MedTech cybersecurity
- Hospital networks: VLANs, PACS, HL7, DICOM, FHIR, cloud integration
Module 2 — Regulations, Standards & Compliance
- FDA Premarket Cybersecurity Guidance (2023)
- FDA Postmarket Management (PMCSA)
- AAMI SW96:2023 Security Risk Management
- AAMI TIR97:2019 Postmarket Risk Framework
- AAMI SW91:2018 Defect Classification
- IEC 81001-5-1 Health Software Security
- IEC 62304 Secure SDLC requirements
- ISO 14971 cybersecurity integration
- SBOM, CBOM requirements and templates
- CVD (Coordinated Vulnerability Disclosure)
Module 3 — Risk Management for Medical Devices
- Security Risk Management Plan (SRMP)
- Cyber risk in safety-critical systems
- Hazard analysis vs cybersecurity risk analysis
- Threat modeling (STRIDE, LINDDUN, STPA-Sec)
- Attack vectors:
- Wireless (BLE, Wi-Fi, BT)
- Implantable devices
- Cloud APIs
- Firmware
- Hospital networks
- Risk scoring (CVSS v4 + safety linkage)
Workshop:
Create a cybersecurity risk management plan for a connected infusion pump.
Module 4 — Secure Architecture & Design
- Secure-by-design for embedded/IoT medical devices
- Hardware security: secure boot, TPM/TEE, memory protection
- Software security: least privilege, secure APIs, secure firmware
- Cloud & mobile app security
- Cryptography for medical devices:
- Key management
- Mutual authentication
- Data encryption
- Firmware signing
- Secure interfaces (USB, UART, JTAG lockout)
Exercise:
Model a secure architecture for an ECG monitoring device.
Module 5 — Secure Development Lifecycle (SDLC)
- Integrating security into IEC 62304 lifecycle
- Threat modeling in design input/output
- Secure coding for C/C++/Python embedded systems
- SBOM/CBOM creation and maintenance
- Patchability, secure update mechanisms
- Firmware integrity verification
DAY 2 — Testing, Incident Response, Postmarket, and Certification Prep
Module 6 — Cybersecurity V&V: Testing, Fuzzing, Pen Testing
- Security V&V plan aligned with FDA expectations
- Interface security testing
- Penetration testing methodology for medical devices
- Fuzzing (protocol, API, interface)
- Static Analysis (SAST)
- Dynamic Analysis (DAST)
- Memory and fault injection testing
- Secure logging and audit trails
Hands-on:
Perform fuzz testing on a simulated medical device API.
Module 7 — Postmarket Cybersecurity (TIR97:2019 & SW96:2023)
- Continuous monitoring program
- Vulnerability intake & triage
- Patch deployment strategies
- End-of-life cybersecurity plans
- Customer security documentation
- Incident response coordination
- FDA recall and field safety corrective actions
Exercise:
Build a postmarket cybersecurity surveillance program.
Module 8 — Coordinated Vulnerability Disclosure (CVD)
- Researcher engagement and vendor responsibilities
- CVD program structure
- Security advisories
- ICS-CERT, CISA, MITRE interfaces
Module 9 — Incident Response for Medical Devices
- Incident response requirements
- Safety + cybersecurity co-analysis
- Forensics and chain-of-custody
- Hospital network incident management
Module 10 — Pre-market Submission Package (FDA)
Create the cybersecurity artifacts required for:
- Threat modeling & risk assessment
- Security architecture documentation
- SBOM / CBOM
- V&V evidence
- Pen test report
- Updateability & patching plan
- User security controls
- Labeling requirements
Hands-on:
Build a template FDA cybersecurity submission package.
Module 11 — Certification Exam Review & Competency Demonstration
- Domain coverage
- Sample questions
- Case-study review
- Practical security scenario analysis
CMDCS Certification Exam
Format
- 40 questions
- Multiple choice + scenario-based
- 90 minutes timed exam
- Passing score: 70%
Question Types
- Knowledge questions
- Scenario-based cybersecurity cases
- Architecture analysis
- Threat modeling evaluations
- Compliance mapping tasks
Exam Domains & Weights
1. Medical Device Cybersecurity Fundamentals
Device types, IoMT ecosystem, threat surface
10%
2. Regulatory, Standards, and Compliance
FDA, SW96, TIR97, IEC 62304, ISO 14971, 81001
20%
3. Security Risk Management & Threat Modeling
Attack models, cybersecurity risk, hazard linkage
20%
4. Secure Architecture & Design Controls
Secure design patterns, cryptography, interface protection
15%
5. Secure Development Lifecycle (SDLC)
SBOM/CBOM, secure coding, update mechanisms
10%
6. Cybersecurity Testing & Validation
Pen testing, fuzzing, static/dynamic analysis
10%
7. Postmarket Cybersecurity Management
Monitoring, CVD, patches, incident response
10%
8. FDA Submission & Documentation
Security documents, V&V evidence, artifacts
5%
Advance your expertise where patient safety meets cybersecurity. Enroll in the Certified Medical Device Cybersecurity Specialist (CMDCS) Certification Program by Tonex today and position yourself at the forefront of healthcare technology protection.