Our Core Series of courses will help you build your knowledge and expertise across the elements of your cybersecurity program and help prepare you for more successful regulatory submission experiences.

Course 101 • FDA Cybersecurity Submission Essentials: Understanding the Requirements, Deliverables, and Development Timeline ​

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Description: This course is modeled after the training Matt Hazelett developed for FDA review staff, but it has been adapted for medical device manufacturers. This course will go into the details of the FDA submission  deliverables needed for medical device cybersecurity throughout the total product lifecycle. It will help ensure your organization is aware of how to meet regulatory requirements for submissions and outline when the deliverables should be created during the development process. 

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Audience: This course is best suited to those who already have awareness of medical device cybersecurity and are interested in a more detailed overview of how to manage medical device cybersecurity over the total product lifecycle. This may include software engineers, cybersecurity staff, regulatory affairs staff, and management.

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Planned Agenda:

1. Regulation of Cybersecurity – US focus (more in depth than Cybersecurity for Beginners – 001)

2. TPLC Security Objectives and Goals

3. Concept/Planning

4. Security Risk Management

5. Design and Development

6. Testing – Verification and Validation

7. Labeling

8. Cybersecurity Management Plan

9. Postmarket Requirements – Maintenance​​

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Course 201 • Product Security Program Design: From QMS to eSTAR - Generating submission-ready eSTAR cybersecurity docs from your QMS 

Description: This course goes “under the hood” of all things medical device cybersecurity including creating documentation for cybersecurity within your quality management systems, current standards, and design.

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Audience: This is for medical device cybersecurity team members and regulatory affairs personnel who are looking to set up their organizations for success moving forward and who already have general familiarity with the basics for cybersecurity submissions.

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Planned Agenda:

1. Why does this feel so difficult, so fast?

2. Concepts and challenges

3. Generating submission-ready eSTAR documents from your QMS

4. Overview of cybersecurity standards and their use​

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Course 301 • FDA Insider: Behind the Scenes Look at Cybersecurity Reviews, Deficiencies, and FDA Interactions  

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Description: This course will give you a detailed look behind the Zoom meetings, conference rooms, deficiency letters, and additional information request emails of the FDA. This course will cover cybersecurity submission strategies, everything you need to know about deficiencies, and how to have success with FDA reviewers that you won’t find anywhere else.

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Audience: This is for medical device cybersecurity team members and regulatory affairs personnel who are looking for insider information on the FDA cybersecurity review process.

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Planned Agenda:

1. Submission strategies

2. Effectively managing deficiencies

3. Success with reviewers​

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