Regulatory Strategy Sprint (2 weeks)
From $3,500
Scope fit for 1 device family
- Intended use & indications mapping
- Likely pathway (510(k), De Novo, exempt)
- Key standards & guidance map
- Risk & testing roadmap (draft)
Pricing
Transparent options for every stage
Choose flat-rate packages for predictable deliverables, or engage us on a flexible retainer for in-flight projects.
Flat-rate packages
Monthly retainers
On-demand advisory
Consulting fees are separate from official FDA user fees.
Flat-rate Packages
Predictable scope. Clear timelines.
510(k) Predicate & Gap Review (Lite)
From $2,500
Rapid comparative assessment
- Predicate short-list (up to 5)
- Substantial equivalence gap highlights
- Draft bench test matrix outline
- 30-min readout & next steps
Q-Submission (Pre-Sub) Packet
From $6,000
Target 3–4 weeks, device-dependent
- Draft Pre-Sub questions & briefing package
- One review cycle with your team
- Meeting coaching & logistics support
More Services
Add-ons & specialized support
| Service | What’s included | Typical timeline | Price |
|---|---|---|---|
| 513(g) Request | Draft request, device description, proposed classification & rationale, one internal review cycle | 3–4 weeks | From $4,500 |
| Quality System “Mini” (SOP set) | Right-sized procedures (Document Control, Training, CAPA, Complaints, Design Control starter), templates & rollout plan | 4–6 weeks | From $9,500 |
| Human Factors Plan & URRA | Use-related risk analysis, critical tasks, formative plan and protocol outline | 2–4 weeks | From $4,000 |
| Bench Test Plan Matrix | Standards map, verification matrix, acceptance criteria outline; vendor suggestions | 2–3 weeks | From $3,000 |
| Labeling / IFU Package | Draft IFU, labeling review against standards & guidance, one revision cycle | 1–2 weeks | From $2,000 |
| Design History File Buildout | DHF structure, checklist, gap close plan, templates | 2–6 weeks | Call for detailed pricing |
| Emergency Regulatory Response | Rapid assessment, priority plan, targeted documentation fixes | Expedited | Call for detailed pricing |
Flexible Engagements
Retainers & on-demand advisory
Starter Retainer
Ideal for early discovery & targeted questions
- ~10 hours/month
- Priority async Q&A
- Rolling month-to-month
Growth Retainer
For active verification & documentation work
- ~20–30 hours/month
- Roadmap & progress check-ins
- Preferred ad-hoc meeting slots
On-Demand Advisory
As-needed expert sessions (remote)
- Book in 60–90 min blocks
- Follow-up notes & actions
- Great for rapid decisions
Note on FDA fees: Consulting fees do not include official FDA user fees (e.g., 510(k) standard/small business). See current rates on the FDA site.
View FDA MDUFA fees
FAQ
Pricing questions, answered
What drives price?
Risk class, novelty, software usage, clinical claims, testing complexity, and the completeness of existing documentation are the biggest drivers.
Can we mix flat-rate and retainer?
Yes—many clients run a flat-rate sprint to set direction, then move to a monthly retainer to execute the roadmap.
Do you discount for startups?
We keep packages lean for early teams and can scope phases to match milestones. Ask about small-business options.