FDA Cybersecurity Readiness Consultation - Free (No Form of Payment Required)

Designed for SaMD developers, digital health teams, and medical device manufacturers who want a clear-eyed assessment of where they stand against current FDA cybersecurity expectations, before it becomes an audit finding or a submission delay.

This complimentary consultation is a structured 45-minute conversation with an experienced medical device regulatory consultant. No sales pitch. Just an honest, expert review of your current cybersecurity posture relative to FDA premarket and post-market guidance requirements.

What We Cover

Depending on your situation and priorities, the conversation will focus on the areas most relevant to your current stage. This may include:

• Your device architecture and whether it is connected, networked, cloud-based, or integrated with external systems
• Alignment with current FDA cybersecurity expectations for medical devices
• Threat modeling and secure product development practices
• Software bill of materials (SBOM) readiness and component transparency
• Vulnerability management and post-market cybersecurity processes
• Cybersecurity risk documentation and integration with ISO 14971 risk management activities
• Documentation readiness for FDA submissions, audits, or internal design reviews

What You Walk Away With

A clear picture of your most significant cybersecurity documentation gaps, a prioritized sense of where to focus remediation effort, and a straightforward recommendation on whether a productized solution, a custom consulting engagement, or a combination of both is the right next step for your organization.

Who This Is For

This consultation is built for teams preparing for an FDA premarket submission, responding to an audit finding, or simply trying to understand where their cybersecurity documentation stands against current regulatory expectations. It's equally valuable for first-time submitters and experienced teams navigating the post-2023 FDA cybersecurity guidance landscape.

How It Works

We will contact you for a time that works for you. You'll receive a brief pre-call questionnaire to help focus the conversation on your specific product, lifecycle stage, and regulatory context. No preparation required beyond that.

What This Is Not

This consultation is not a substitute for a full cybersecurity strategy engagement, submission support, or ongoing quality management consulting. If your needs extend beyond documentation and readiness assessment, contact us for something that may be a better fit.

Typical Outcomes From This Call

Every situation is different, but most teams leave this call with one of the following outcomes:

Outcome 1: Documentation Alignment

Your cybersecurity thinking is generally on the right track. We identify a few areas where documentation or evidence needs to be strengthened to better align with FDA cybersecurity expectations.

Outcome 2: Targeted Cybersecurity Documentation Gaps

We identify several important documentation gaps — commonly in areas such as threat modeling, secure development processes, SBOM preparation, vulnerability management planning, or cybersecurity risk documentation. We outline a practical path to close these gaps.

Outcome 3: Cybersecurity Framework Needs Structure

Your device architecture may include networked, cloud-based, or connected components, but the cybersecurity documentation framework has not yet been formally structured. In these situations we typically recommend establishing a structured cybersecurity documentation package aligned with current FDA expectations.