510(k) Cybersecurity Consultants Los Angeles & Nationwide
Find 510(k) cybersecurity consultants who help you meet FDA’s cybersecurity expectations for devices with software—threat modeling, SBOM, vulnerability management, and submission content. Many work with clients in Los Angeles, California, and nationwide.
- SAMD and 510(k) cybersecurity documentation
- FDA Pre-Sub, eSTAR, and RTA support
- Threat modeling, SBOM, and vulnerability management
Compare profiles · Request quotes · Specify your device and scope
What are 510(k) cybersecurity consultants?
510(k) cybersecurity consultants are regulatory and technical experts who help medical device manufacturers meet FDA’s cybersecurity expectations for devices that contain software or are connected. They support preparation of 510(k) (and related) submissions so that cybersecurity documentation—design, SBOM, vulnerability management, and labeling—aligns with FDA guidance.
The FDA has made clear that cybersecurity is a quality system consideration and that premarket submissions for devices with software should address it. In September 2023 the Agency issued final guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, which describes FDA’s recommendations for design, documentation, and submission content (FDA Guidance). Consultants help you interpret and apply this guidance for your device.
Many of these experts serve clients in Los Angeles, across California, and nationwide. Throughout this page we cite FDA and related sources; see Sources and references at the bottom.
Why FDA expects cybersecurity in 510(k) submissions
Medical devices that incorporate software or are network-connected can be vulnerable to cybersecurity threats. The FDA expects manufacturers to consider cybersecurity throughout the product lifecycle and to include appropriate information in premarket submissions.
Key expectations referenced in FDA’s 2023 cybersecurity guidance include:
- Security by design — Threat modeling, secure design principles, and risk management that considers cybersecurity risks.
- SBOM (Software Bill of Materials) — Transparency about software components so vulnerabilities can be identified and managed.
- Vulnerability management — Processes for identifying, assessing, and addressing vulnerabilities, including postmarket updates.
- Premarket submission content — Documentation in the submission that addresses cybersecurity (e.g. in eSTAR or traditional 510(k)) so reviewers can assess the device’s security posture.
Consultants who specialize in 510(k) cybersecurity help you translate these expectations into a submission-ready package and, where relevant, into your quality system (e.g. 21 CFR Part 820).
Source: FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023).
What 510(k) cybersecurity consultants do
Typical services include:
- Cybersecurity strategy for 510(k) — Determining what FDA will expect for your device type (e.g. Software as a Medical Device, connected devices) and planning evidence and documentation.
- Threat modeling and risk assessment — Aligning with FDA’s guidance on security by design and risk management, and documenting results for the submission.
- SBOM and vulnerability management — Helping you produce and maintain SBOMs and vulnerability management processes that meet FDA expectations.
- Premarket submission authoring — Drafting or completing the cybersecurity-related sections of your 510(k) or other premarket submission (e.g. eSTAR format).
- Pre-Sub (Q-Sub) support — Using the FDA Pre-Submission Program to get feedback on your cybersecurity approach before you submit.
- RTA and AI response — Addressing Refuse-to-Accept or Additional Information requests related to cybersecurity.
Many consultants also support broader 510(k) and FDA work (e.g. predicate analysis, full eSTAR assembly). When comparing providers, ask specifically about their experience with FDA’s cybersecurity guidance and with devices similar to yours.
See FDA 510(k), Cybersecurity (Digital Health Center of Excellence), and Cybersecurity (SAMD) on Cruxi.
FDA consultant near me: Los Angeles and nationwide
Searches like "fda consultant near me" or "510k cybersecurity consultants los angeles" are common. In practice, many FDA and 510(k) consultants work with clients remotely across the US, so a consultant based in Los Angeles, another city, or a different state can still support you effectively.
What matters more than location is fit: experience with your device type (e.g. software, connectivity, clinical use), submission pathway (510(k), De Novo), and cybersecurity expectations. Directories like the one on this site let you compare claimed providers by profile and request quotes without being limited to a single metro area.
If you prefer a consultant familiar with the Los Angeles or California medtech ecosystem, look for that in their profile or ask when requesting a quote. Otherwise, prioritize expertise and responsiveness.
What to have ready before your first consultant call
Being prepared helps you get useful quotes and use the call well:
- Device and software description — What the device does, whether it’s SAMD or has embedded/connected software, and how it connects (if at all) to networks or other systems.
- Current documentation (if any) — Existing threat model, SBOM, or design docs. If you have nothing yet, say so; the consultant can scope from “we need everything” to “we need submission sections only.”
- Regulatory goal — First 510(k) with cybersecurity, Pre-Sub on cybersecurity only, RTA/AI response on cybersecurity, or full submission authoring.
- Timeline and budget range — When you need to submit (or respond) and whether you’re considering fixed fee vs time-and-materials.
You don’t need a complete security dossier. Enough context for the consultant to propose a realistic scope is sufficient.
Typical deliverables and timeline
510(k) cybersecurity engagements are often scoped as:
- Cybersecurity strategy or gap assessment — What FDA will expect for your device, what you have vs lack, and a plan to close gaps. Often 2–4 weeks depending on complexity.
- Threat model and risk assessment — Documented threat model and cybersecurity risk analysis aligned with FDA guidance. May be part of a larger risk file (e.g. ISO 14971).
- SBOM and vulnerability management — Producing (or improving) SBOM and defining vulnerability management processes. Consultants may deliver templates and guidance or hands-on support.
- Submission content — Drafting the cybersecurity-related sections of your 510(k) or eSTAR. Clarify how many revision rounds and who provides inputs (you vs consultant).
- Pre-Sub support — Preparing the cybersecurity portion of a Pre-Sub package and (optionally) attending the meeting. Usually scoped per meeting.
Get deliverables and revision rounds in writing. For general scoping and pricing, see How to scope a 510(k) consultant project and 510(k) consultant pricing models.
Red flags when hiring for 510(k) cybersecurity
Watch for the following when evaluating consultants:
- Can’t reference FDA’s 2023 cybersecurity guidance — They should be able to discuss security by design, SBOM, vulnerability management, and submission content in line with the guidance.
- No examples with SAMD or connected devices — If your device is software or connected, ensure they’ve done 510(k)s that included cybersecurity for similar device types.
- Scope and deliverables not in writing — Insist on a clear statement of work: what they deliver (threat model, SBOM, submission sections), revision rounds, and who owns what.
- Promises specific FDA outcomes — No one can guarantee clearance or that FDA won’t ask for more. They can commit to deliverables and process, not agency decisions.
- Vague on who does the work — Ask for the named person(s) and their experience with FDA cybersecurity submissions.
For more on vetting 510(k) consultants, see 7 red flags when hiring a 510(k) consultant.
Questions to ask in a first call
Use the first call to assess fit and clarify scope:
- How do you use FDA’s September 2023 cybersecurity guidance in your 510(k) work? Can you walk through what you’d expect for a device like ours?
- Have you supported 510(k)s that included cybersecurity for SAMD or connected devices? Can you share anonymized examples or outcomes?
- What exactly would you deliver (threat model, SBOM, submission sections, Pre-Sub package)? How many revision rounds?
- Who would do the work, and what’s their experience with FDA cybersecurity reviews? Who would interact with FDA if we do a Pre-Sub or get an AI request?
- How do you charge (hourly, fixed fee, phased)? What’s in scope vs out of scope for that price?
Comparing answers across two or three consultants will clarify fit and realistic pricing.
How to choose a 510(k) cybersecurity consultant
Practical steps when evaluating providers:
- Confirm cybersecurity-specific experience — Ask how they use FDA’s 2023 cybersecurity guidance (and any device-specific guidances) and for examples of 510(k)s they’ve supported that included cybersecurity content.
- Match device type — Software as a Medical Device (SAMD), connected devices, and embedded software each have different emphasis. Ensure they’ve worked on similar devices.
- Clarify scope — Will they do threat modeling, SBOM, full authoring, or review? What deliverables and how many review cycles?
- Pre-Sub and RTA experience — If you plan a Pre-Sub or have received RTA/AI, ask about their experience with FDA feedback and resubmissions.
Compare 510(k) consultants below and request quotes, or browse the full directory:
510(k) submission services directory · Cybersecurity (SAMD) resource
Compare 510(k) cybersecurity consultants
Compare profiles below and request quotes. Specify your device type (e.g. SAMD, connected device) and need (e.g. threat model, full submission, Pre-Sub, RTA response) so consultants can scope accurately.
FAQ
What should I have ready before my first consultant call?
Bring a device and software description (SAMD, connected, or embedded), any existing docs (threat model, SBOM), your regulatory goal (first 510(k), Pre-Sub, RTA response), and timeline/budget range. You don’t need a complete security dossier—enough for the consultant to propose scope is sufficient. See What to have ready before your first consultant call above.
What are 510(k) cybersecurity requirements?
FDA expects cybersecurity to be addressed in 510(k) submissions for devices with software. The September 2023 guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions describes recommendations for security by design, SBOM, vulnerability management, and submission content. Consultants help you implement these and document them in your 510(k) or eSTAR. See FDA Guidance and Sources and references below.
What are common RTA or AI reasons related to cybersecurity?
FDA may refuse to accept or ask for more information when cybersecurity is insufficiently addressed: missing or weak threat model, no SBOM or inadequate vulnerability management plan, or submission sections that don’t clearly describe security controls and residual risk. A consultant can help you close gaps before submission or respond to specific RTA/AI items.
How do I scope fixed-price vs time-and-materials for cybersecurity work?
Fixed price works when deliverables are clear (e.g. threat model + SBOM + submission sections, with defined revision rounds). T&M is often used for discovery-heavy or “we don’t know what we need yet” phases. Ask the consultant what they typically use for your type of scope and get the scope in writing either way. See How to scope a 510(k) consultant project and 510(k) consultant pricing models.
Where can I verify FDA cybersecurity requirements?
FDA’s main cybersecurity guidance for premarket submissions is Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023), available on fda.gov. The Agency’s Cybersecurity (Digital Health Center of Excellence) page links to guidance and updates. We list key sources in Sources and references on this page.
Sources and references
This page cites FDA and related sources so you can verify requirements. All links were current at the time of publication.
- FDA. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023). fda.gov/regulatory-information/.../cybersecurity-medical-devices...
- FDA. Cybersecurity (Digital Health Center of Excellence). fda.gov/medical-devices/digital-health-center-excellence/cybersecurity
- FDA. Premarket Notification 510(k). fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
- FDA. Pre-Submission (Pre-Sub) Program. fda.gov/medical-devices/premarket-submissions/pre-sub-program
- FDA. Device Guidance Documents. fda.gov/medical-devices/device-guidance-documents
- eCFR. Title 21 Part 820 — Quality System Regulation. ecfr.gov/current/title-21/.../part-820
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