A deficiency letter rarely asks how many vulnerabilities you found. It asks why you did not fix the ones you dismissed. ELTON attaches device specific evidence to every disposition, so the answer is already in the submission.
Most tools document what they found. ELTON also documents why the rest do not apply, with proof a reviewer can follow. That second half is what audits are made of.
Fixed findings close themselves. The risk sits in the long tail of entries marked not applicable, because that is where reviewers push.
An additional information request lands on the CVE you dismissed with one sentence, not on the ten you patched. A single weak disposition can stall the whole review cycle.
A severity number on its own invites the follow-up question. Reviewers accept dispositions they can trace from claim to test to evidence without leaving the document.
SBOM, assessment, testing summary, and postmarket plan get written by different people at different times. A contradiction between them is a finding in itself.
An empty test report reads as thin testing, not a secure device. Reviewers ask for coverage, and a bare PDF cannot answer. ELTON answers with the work itself.
Every finding ships with a prescriptive fix, weaknesses included. The report is not empty because nothing was found. It is full because everything was addressed.
Hundreds of test cases generated from the threat model, each traced from requirement to executed result. Coverage a reviewer can count, not take on faith.
Every run, result, rating, and dismissal is timestamped on the record. When FDA asks what you tested, the answer is the log, not a recollection.
The claim we make is specific and we keep it exact: ELTON meets FDA premarket (Section 524B) and postmarket cybersecurity vulnerability testing and management requirements.
Exploitable findings carry proof of exploitation and the fix history. Dismissed findings carry proof of why the attack fails on your device. Nothing rests on engineering opinion alone.
Ratings follow the ELTON CVSS rubric, recognized under the FDA Medical Device Development Tools program. You cite a method FDA has already evaluated instead of defending a homegrown one.
Outputs are structured to drop into the cybersecurity sections of an eSTAR package. ELTON evidence has supported 600+ regulatory submissions.
SBOM, vulnerability assessment, VEX in CycloneDX, and testing evidence all render from the same underlying record, so the documents cannot contradict each other.
When a reviewer cross references your assessment against your SBOM and your VEX, they find one story, because there is only one record to tell it from. Update the record and every document downstream updates with it.
Cybersecurity sections assemble straight from the record: testing evidence, ratings on the recognized rubric, SBOM, and dispositions with proof, aligned to the eSTAR structure reviewers work in.
When a question arrives years later, the disposition still has its evidence attached, tied to the exact release it was made against. No archaeology through old spreadsheets.
ELTON turns the vulnerability file into something a reviewer can trace end to end: finding, disposition, proof.