Regulatory Advisory
A named regulatory expert alongside your team while the device is still being designed.
The pathway to clearance is shaped long before a submission is written — by material choices, component changes and claims decided during design. Advisory is how those decisions get made with the regulatory consequence visible at the time.
Month to month, no contract. Your expert is named when the plan starts, and it is the same person every month.
Materials, components and claims are all still open.
The choices made here are what decide your pathway.
A change at this point means re-testing, not a conversation.
- From
- $950 a month
- Expert time
- 2, 4 or 15 hours a month
- Your expert
- Named, and the same each month
- Commitment
- Month to month
- Extra hours
- $300 an hour
- Workspace
- Complizen.ai Pro, 3 seats
The most expensive decisions are made at the design stage.
A material substitution, a change of supplier, a new component: each one can quietly move a device into a category that requires additional biocompatibility, electrical safety or performance testing.
None of those changes announces itself as a regulatory decision at the time it is made. That is precisely why they are made without one.
of Essential advisory, at $950 a month, bought by catching that one decision before it was locked in.
A single material change can be the difference between no additional testing and $30,000 of it. Not every change is, and we will not pretend otherwise — but one is enough to cover years of advisory.
Asked by clients, in their own words.
None of these arrives labelled as a regulatory question. They arrive as engineering and purchasing decisions with a deadline on them.
- “We are choosing between two materials. Does either one change what testing we need?”
- “If we add this sensor, are we still in the same product code?”
- “We want to claim this on the label. What evidence would FDA expect behind it?”
- “Our supplier is changing a component. Does that affect our pathway?”
- “We have a CE technical file. How much of it will FDA accept?”
Every one of these is cheap to resolve before the decision and expensive to fix afterwards. The cost of asking is an hour. The cost of not asking is whatever the re-test turns out to be.
Six disciplines, not just the submission.
Your hours are not ring-fenced to one topic. Spend them wherever the month actually needs them.
- Regulatory strategy and FDA submissions
- Quality management systems and compliance
- Product engineering and design controls
- Risk management and validation testing
- Operations and vendor management support
- Compliance and quality system training
The hours are the only difference.
Everything else is in all three. Pick the number of hours your development actually needs this quarter, and change it when that changes.
- Essential
- Monthly fee
- $950
- Expert hours a month
- 2 hours
- Full Complizen platform access
- Questions answered in writing between sessions
- Design-stage decision reviews
- StandardRecommended
- Monthly fee
- $1,450
- Expert hours a month
- 4 hours
- Full Complizen platform access
- Questions answered in writing between sessions
- Design-stage decision reviews
- Embedded
- Monthly fee
- $4,073
- Expert hours a month
- 15 hours
- Full Complizen platform access
- Questions answered in writing between sessions
- Design-stage decision reviews
| Feature | Essential | RecommendedStandard | Embedded |
|---|---|---|---|
| Monthly fee | $950 | $1,450 | $4,073 |
| Expert hours a monthWith the same named person each month, scheduled rather than requested. | 2 hours | 4 hours | 15 hours |
| Full Complizen platform access | |||
| Questions answered in writing between sessionsWith the regulatory basis cited, so the reasoning can be filed. | |||
| Design-stage decision reviewsA proposed change assessed against its regulatory consequence before it is made. |
Additional expert hours are $300 an hour beyond the hours in your plan. All three are month to month with no contract — scale up for a heavy design period, and scale down or pause when the device is sitting still.
A regulatory AI assistant is in every plan, not sold beside them.
Enterprise-grade, and built for medical device compliance rather than adapted to it. On its own it is $349 a month.
- Unlimited projects
- 3 seats, add more
- Unlimited AI usage
- SuperagentAn AI FDA expert that returns cited, defensible answers.
- Drafting StudioAI-assisted document writing, with inline suggestions and references.
- Submission BuilderDevice-specific eSTAR drafting, section by section.
- KnowledgeEvery FDA database and guidance document, searchable.
- CollaborationGroup document editing and shared Superagent threads, with an audit trail.
- CloudSecure, versioned document storage your team and ours both work in.
It is also where the two halves of this service meet. Your expert works in the same workspace you do, so the documentation you build during development is already structured the way a submission expects it by the time you file.
Advice you can put in a file.
Most regulatory advice arrives as a phone call. It settles the question in the room and leaves nothing behind, so a year later nobody can say why the decision was made that way.
Answers here come in writing with the regulatory basis cited, so the reasoning can be filed and shown to an auditor or a customer later.
Your hours are scheduled
So expert time is available when a decision is in front of you, rather than weeks later when it has already been made.
Answers are written and cited
Questions between sessions come back in writing with the regulatory basis, which is what makes them worth keeping.
You can see the hours going
Project tasks and timelines live in the workspace, and consulting hours used show in real time — so the balance is never a surprise at the end of the month.
Advisory is the first of three, not all of them.
Preparing a submission is separate work with its own fixed price. If a question turns into a project we say so at that point and quote it.
- Step 1Advisory, during developmentWhile materials, components and claims are still open. Monthly, and you can pause it.
- Step 2Regulatory StrategyOnce the device is settled. The pathway, the predicate and the evidence plan, in writing.
- Step 3The 510(k) buildThe submission itself, prepared and filed. Fixed price, quoted from what the strategy found.
The cheapest time to ask is before the decision.
- From $950 a month
- Month to month
- A named expert
- Pause when the device is still
At a glance
| What it is | Ongoing regulatory guidance during development, with platform access and scheduled expert time. |
|---|---|
| Who it is for | Companies whose device is still in design or development, before a submission is written. |
| Commitment | Month to month. Scale up, scale down or pause as your development cycle requires. |
| Workspace | Complizen.ai Pro on every plan: unlimited projects, three seats (add more), unlimited AI usage, and all six tools. |
| What you can see | Project tasks and timelines you can create and edit, and real-time visibility of the consulting hours you have used. |
| Not included | Preparing a submission. That is the Regulatory Strategy and the 510(k) build, quoted separately. |
| If the device is finished | Advisory is the wrong product. Start with the Regulatory Strategy instead — there are no design decisions left for it to influence. |
Questions people ask
Is this for companies that already sell in the United States?
It is built for companies still in development, where design decisions are still open. Companies already on the market use it too, usually for change assessments and labeling questions.
What if a question turns into a project?
We say so at that point and quote it separately. Advisory covers judgment and guidance. Preparing a submission is separate work with its own fixed price.
Can this replace hiring a regulatory manager?
For a company with one or two devices and a steady product range, it often can — Embedded is fifteen hours a month, which is the point at which it starts to look like a part-time role rather than an advice line. For a company filing several submissions a year an internal hire is usually better value, and we will say so.
Do we get the same person each month?
Yes. Your expert is named when the plan starts.
Can we start advisory and move to a submission later?
That is the usual sequence. Advisory during development, then the Regulatory Strategy when the device is settled, then the build.
What happens if we do not use our hours in a month?
Development does not run at a constant rate, so neither does the need for advice. The plan is month to month: scale up for a heavy design period, scale down or pause when the device is sitting still, and start again when it moves.
Can we have the workspace without the consulting hours?
Yes. Complizen.ai is sold on its own — Pro is $349 a month, and there is a free tier for early-stage companies. Advisory is the version with a named regulatory expert and scheduled hours attached to it. If you only want the software, start on the platform pricing page.
What if we go over our hours in a month?
You are not cut off and you are not renegotiating mid-project. On-demand overflow hours are available at a fixed, published rate of $300 an hour, and the hours you have used are visible in the workspace in real time, so you can see it coming rather than finding out on the invoice.
How many people can use the workspace?
Three seats are included on every plan, and you can add more at any time. Every plan gets Complizen.ai Pro — unlimited projects, unlimited AI usage, and all six tools.
Which plan should we start on?
Essential, unless design decisions are already coming at you weekly. Every plan includes the same things — the only question is how many hours a month you need, and that is the one thing you can change later. Tell us where the device is and we will say which one fits, or whether you need one yet.