Clinical Research Training Academy

Course Description

This intensive 1-day training program provides a deep, practical understanding of FDA Medical Device cybersecurity regulatory requirements.

Participants will learn how to design, document, and submit compliant software and cybersecurity information for FDA 510(k), De Novo, and PMA submissions. The course shows how software/hardware risk, threat modeling, and security controls align with FDA's Quality Management System Regulation (QMSR), Cybersecurity Guidance, and IMDRF medical device cybersecurity principles.

Real-world examples and interactive workshops prepare attendees to author and assemble the cybersecurity documentation FDA expects in a premarket submission, from the security risk management report through controls, architecture, and labeling, and to understand FDA's postmarket vulnerability response expectations.

Course at a Glance

1-Day Live Virtual Workshop

1 Full Day of Interactive Learning

Intensive, instructor-led sessions

September 18, 2026

Upcoming Virtual Workhop

9:00 AM - 4:00 PM EST

Small-group, live instructor-led sessions

Price : $1995 USD

Location:

Participate from anywhere with stable internet

Certificate of Completion from CRTA

Recognized professional credential

Faculty Director: Jordan John

Limited Seats - Secure Your Spot Early!

Terms & Conditions

Learning Objectives

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

•
1. Understand FDA's latest cybersecurity guidance and its integration into the design and submission lifecycle.
•
2. Apply Section 524B "cyber device" requirements and the Secure Product Development Framework (SPDF) to premarket submission planning.
•
3. Develop and maintain Pre-market Cybersecurity documentation in line with FDA expectations.
•
4. Develop Risk Management files in line with FDA and AAMI TIR57 best practices.
•
5. Prepare cybersecurity documentation for 510(k), De Novo, or PMA submissions.
•
6. Implement post market cybersecurity processes, including coordinated vulnerability disclosure (CVD) and incident response.

Who Should Attend

•
Regulatory Affairs and Quality Professionals
•
Cybersecurity Specialists in MedTech
•
Software Developers and System Architects
•
Connected Device and Digital Health Innovators
•
FDA Submission and Compliance Teams
•
Risk Management and Product Security Leads

Course Outline

FDA Medical Device Cybersecurity Regulatory Landscape and Risk Management

Module 1 – FDA Medical Device Cybersecurity Regulatory Landscape

•Section 524B “cyber device” requirements and FDA’s authority to refuse to accept submissions

•FDA’s current cybersecurity guidance (February 2026, QMSR-aligned) and its place in the submission lifecycle

•How cybersecurity fits the QMSR and the Secure Product Development Framework (SPDF)

•The cybersecurity documentation FDA expects in a premarket submission

•Workshop 1: Determine cyber device status and the documentation a sample product would require

Module 2 – Security Risk Management Documentation

•The security risk management report and its role in the submission (AAMI TIR57 / ANSI-AAMI SW96)

•Cybersecurity risk assessment documentation and traceability

•Software Bill of Materials (SBOM) support plan documentation

•Assessment of unresolved anomalies and cybersecurity metrics

•Workshop 2: Review a sample security risk management report package for completeness against FDA expectations

Module 3 – Security Architecture, Controls, and Labeling Documentation

•Security architecture views and supporting documentation

•Cybersecurity controls documentation and traceability to risks

•Cybersecurity labeling: security-related device description (CSD) and MDS2

•Communicating security information to users

•Workshop 3: Build a cybersecurity labeling and architecture documentation checklist

Cybersecurity Management Plans and Postmarket Requirements

Module 4 – Plans, Procedures, and the Cybersecurity Management Plan

•Section 524B documentation requirements (plans and procedures, processes, SBOM)

•The cybersecurity management plan and what FDA expects to see

•Coordinated vulnerability disclosure (CVD) plan as a submission element

•Assembling a coherent submission documentation package aligned to the QMSR

•Workshop 4: Build a cybersecurity documentation checklist mapping each FDA-expected document to your submission

Module 5 – Postmarket Cybersecurity

•Overview of FDA’s Postmarket Management of Cybersecurity guidance and how it complements the 2026 premarket guidance

•Controlled versus uncontrolled risk and evaluating risk of patient harm

•Vulnerability monitoring, coordinated disclosure, and information sharing (ISAO)

•When postmarket changes may require reporting (21 CFR Part 806) versus routine updates

•Case Study: A real FDA cybersecurity recall through a postmarket documentation lens

Closing Session

•Knowledge Assessment Quiz

•Participant Q&A and Discussion

•Certificate of Completion

Interactive Activities

•4 Hands-On Workshops: Documentation reviews, controls-to-risk mapping, labeling and architecture checklists, and submission package planning.
•Real-World Case Studies: FDA recalls and cybersecurity submissions.
•Live Polls & Group Discussions: Reinforce understanding through scenario-based learning.
•Mock Documentation Review: Teams critique a sample device cybersecurity documentation package for compliance gaps.
•Final Quiz & Instructor Q&A: Summarizes and applies key takeaways.