Submission readiness
FDA 510(k) eSTAR Mock Review
Automated pre-submission review focused on deficiencies, evidence gaps, consistency, and readiness.
$4,950 initial review
Optional prepaid re-evaluation: $2,475
LiveRegulatory intelligence for medical devices
Regulatory work, without the guesswork.
Focused intelligence for submission readiness, regulatory strategy, evidence review, software, cybersecurity, quality, clinical, human factors, and more. Choose the assessment that fits your device. Availability is shown on each card.
25 assessmentsSpecialized modules
3 marketsU.S. · Canada · EU
Per-useNo subscription required
Featured solutions
Start where the risk is highest.
Transparent per-use pricing for the work medical device teams most often need before a submission, market decision, or technical review.
Market strategy
Regulatory Strategy
Structured market-access strategy covering pathway, classification, evidence expectations, and submission planning.
$4,950 initial assessment / market
Optional prepaid re-evaluation: $2,475
LiveClose the findings. Return with updates.
Add your next review,
at half the price.
At your initial checkout, add one future re-evaluation for 50% of the original assessment fee. Update your evidence and redeem the prepaid credit from the same project in the client portal. Your original and updated reports remain available separately.
Available across all 25 Regulatory Intelligence modules for the same device, project, module, and assessment scope; Regulatory Strategy also requires the same market. A new device, module, market, or scope uses the initial fee. The Q-Sub two-stage package is $4,950: $3,950 initial review plus a $1,000 prepaid add-on. Its separately priced second-review reference remains $1,950. Prices are in USD; applicable taxes are added at checkout.
Assessment library
Specialized when you need it.
Search the full regulatory intelligence library by assessment name or family. FDA 510(k) eSTAR Mock Review is live. All 25 core modules are available in the client portal with transparent per-use pricing.
How it works
A focused path from evidence to decision.
Choose your assessment in the client portal, create a project, and provide the evidence for your device and target market.
01
Choose the work
Start FDA 510(k) eSTAR Mock Review or Regulatory Strategy in the client portal. Choose any of the 25 core assessments in the client portal.
02
Provide the evidence
Create a project and provide the relevant documentation and device profile for the assessment you selected.
03
Receive controlled outputs
Get structured findings, recommendations, and traceability, with optional professional regulatory review.
Complex program?
Build the right combination.
Compare markets, assessments, and cross-domain review options for your device program.