Submission readiness
FDA 510(k) eSTAR Mock Review
Automated pre-submission review focused on deficiencies, evidence gaps, consistency, and readiness.
$4,950 per review
Live
Regulatory 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.
23 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 per market
Live
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. Additional modules are priced independently and available by request.
How it works
A focused path from evidence to decision.
Start a live assessment in the client portal, or request another module and we will confirm availability and scope before work begins.
01
Choose the work
Start FDA 510(k) eSTAR Mock Review or Regulatory Strategy in the client portal. Other assessments are available by request.
02
Provide the evidence
For live assessments, create a project and provide the relevant documentation and device profile. For other modules, we will confirm scope first.
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.