Invite-Only Startup WorkshopRequest an invite
Build the 24 FDA cybersecurity documents with confidence.
This month's intensive workshop equips founders and engineering leaders with the templates, narratives, and review tactics required to defend the FDA's 24-document cybersecurity expectation for software-containing devices.
Wednesday, October 23 • 1:00 PM ET
Invite only
Virtual (Zoom)
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Inside the October session
We'll co-create the critical documents the FDA now expects for every software-enabled device, highlighting differentiators that help startups demonstrate maturity without heavyweight bureaucracy.
- Secure product development framework and planning documentation
- Comprehensive threat model, SBOM, and software architecture description
- Risk management file updates aligned to IEC 14971 and AAMI TIR57
- Cybersecurity testing, validation plans, and postmarket surveillance strategy
What to expect
- Hands-on working session with CyberMed strategists reviewing your existing documentation.
- Annotated templates for each of the 24 documents, ready to customize for your device architecture.
- Mock reviewer Q&A so you can rehearse responses before submitting.
Who should join?
Founders, heads of engineering, and regulatory leads at venture-backed medical device startups preparing for pre-submissions, 510(k), or De Novo applications involving software components.