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MD QMS Apex · Security engineering
FDA premarket cybersecurity
If your device includes software and has the ability to connect to the internet, the FDA treats it as a cyber device and expects a full security file in your submission. We assess where you stand and build the evidence.
Why it matters
Under section 524B of the FD&C Act, submissions for cyber devices must include a software bill of materials (SBOM), a plan to monitor and address post-market vulnerabilities including coordinated disclosure, and evidence of processes that provide reasonable assurance the device is secure.
The same evidence supports EU MDR cybersecurity requirements (Annex I, section 17) and MDCG 2019-16 guidance, so one well-built security file can serve both markets.
Who it’s for
- SaMD and connected-device companies preparing a 510(k), De Novo or PMA
- Manufacturers that received FDA questions on cybersecurity
- Teams asked for an SBOM by hospital customers
What’s included
- Scored readiness assessment against current FDA premarket cybersecurity expectations
- SBOM quality review (SPDX, CycloneDX or spreadsheet formats)
- Threat modelling and security risk management aligned with ISO 14971
- Security architecture views, testing plan and labelling content
- Post-market vulnerability management and coordinated disclosure plan
- Penetration-test scoping and test specifications, delivered with a testing partner
Deliverable
Readiness report and remediation plan, then a submission-ready security file.
Everything we write is yours to own and maintain. We stay available for auditor or reviewer questions on anything we produced.
How it works
Discover
A free 30-minute call to understand your product, markets and deadline.
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Questions we’re often asked
We already have an SBOM from our build tools. Is that enough?
It is a good start. The assessment checks whether it is complete, maintained and supported by the vulnerability-management process that the FDA expects to see around it.
Do you run penetration tests yourselves?
We scope the testing and write the test specifications, and work with specialist testing partners to execute them, so the results feed straight into your security file.
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Talk to us about FDA cybersecurity
Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.