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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 slides, 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 — which may include your threat modeling and risk control documentation, SBOM status, secure development lifecycle practices, traceability between threats and verification evidence, and your overall readiness for a premarket submission or regulatory inspection.
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.
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 slides, 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 — which may include your threat modeling and risk control documentation, SBOM status, secure development lifecycle practices, traceability between threats and verification evidence, and your overall readiness for a premarket submission or regulatory inspection.
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.