FDA–MDR Cybersecurity Submission & Documentation Specialist Fundamentals

FDA–MDR Cybersecurity Submission & Documentation Specialist Fundamentals Training by Tonex

Built for teams navigating U.S. FDA and EU MDR expectations, this program blends regulatory strategy with hands-on documentation practice. Participants translate guidance into complete, consistent, and audit-ready submissions while mastering artifacts like SBOMs, threat models, and traceable technical files. Cybersecurity is a throughline, aligning product security claims with evidence, controls, and risk acceptance. You will learn to frame vulnerabilities, mitigations, and residual risk in a way regulators understand. By the end, you can organize dossiers that withstand reviews, minimize back-and-forth, and accelerate secure market entry.

Learning Objectives

• Map FDA and MDR pathways to device scope and risk classes
• Build submission roadmaps and documentation trees that avoid rework
• Produce complete SBOMs with versioning and vulnerability traceability
• Document threat modeling steps, assumptions, and residual risk clearly
• Align verification, validation, and usability files with risk controls
• Communicate cybersecurity posture, controls, and monitoring plans effectively

Audience

• Regulatory Affairs Specialists
• Quality and Compliance Managers
• Medical Device Engineers
• Product Security Managers
• Technical Writers and Documentation Leads
• Cybersecurity Professionals

Course Modules

Module 1 – Premarket FDA

• Submission types overview
• Content of premarket files
• Cybersecurity documentation set
• Risk management alignment
• V&V and evidence mapping
• Reviewer Q&A tactics

Module 2 – MDR Technical File

• GSPRs and mapping
• Technical documentation core
• Clinical and PMS links
• Software lifecycle files
• Change control and updates
• Notified Body expectations

Module 3 – SBOM Requirements

• SBOM structure and depth
• Component identification rules
• Versioning and provenance
• Vulnerability disclosure flows
• Patch and update records
• Supplier attestation handling

Module 4 – Threat Modeling Docs

• Scope and asset definition
• Abuse and misuse cases
• Attack surfaces and STRIDE
• Risk scoring and rationale
• Controls and mitigations
• Residual risk statements

Module 5 – Audit Readiness

• Document control hygiene
• Objective evidence trails
• Traceability and matrices
• Internal mock audits
• CAPA and action logs
• Communication playbooks

Module 6 – Regulatory Templates

• Submission checklist packs
• SBOM reporting template
• Threat model report shell
• Risk memo and summary
• Secure update plan form
• Review comment tracker

Elevate your submissions from adequate to exemplary. Enroll now with Tonex to streamline FDA–MDR documentation, demonstrate robust cybersecurity posture, and move your medical device to market with confidence.