Free assessments
Find out where you stand before you spend on consulting
Two tools you use on your own, in a few minutes, with no sign-up and no cost. One tells you whether your diagnostic product is ready for ANVISA. The other, how mature your innovation project is. Both return a report naming the gaps and what to do next.
ANVISA Readiness
Classifies your in vitro diagnostic product into a risk class under the rules in Annex I of RDC 830/2023, compares it with the FDA and IVDR pathways, and scores your dossier readiness against 16 regulatory criteria.
Who it is for
Biotechs, manufacturers and distributors with an IVD product in development, unregistered or with a registration under way in Brazil. The tool is in Portuguese.
What you receive
- Suggested risk class (I to IV) and pathway — notification or registration
- The classification rule applied, with its technical rationale
- Readiness score and a map of the dossier gaps
- Prioritised action plan, as a PDF
Time about 10 minutes · Cost free · Sign-up not required
TRL Level Finder
Identifies your project’s technology readiness level, from TRL 1 to 9, on the same scale used by NASA, ESA, Horizon Europe and Finep — the one funding calls require at submission.
Who it is for
Anyone submitting a project to a funding call, raising investment or needing to state a TRL in a proposal. Available in English and Portuguese.
What you receive
- TRL level calculated from 27 criteria
- What is missing to reach the next level
- Technical risks and evidence gaps
- Recommended next steps, as a PDF
Time about 5 minutes · Cost free · Sign-up not required
How it works
1
You answer
Objective questions about the product or the project. No unnecessary jargon, and no documents requested.
2
The analysis runs
The classification is computed by an explicit rule, and the write-up is drafted by AI from the regulations in force.
3
You get the report
With the gaps named, the regulation that applies to each one, and what to do next. As a PDF, ready to take into a meeting.
Both tools are for initial guidance. The report is indicative: it does not replace the opinion of a qualified professional and cannot be used as a submission document to ANVISA or to a funding agency.
And after the assessment?
The report shows where the gaps are. Closing them is consulting work — and it is what we do across our nine service packages. If the result points to a regulatory pathway, start with Go-to-Brazil Program. If it points to missing performance data, with Scientific Readiness. If you are assessing a third-party technology, with Scientific Due Diligence.