Cybersecurity evidence, organized for FDA review.
Eureka helps SaMD and regulated software teams turn application security workflow activity into cybersecurity documentation teams can use and stand behind.
30-day free trial. No credit card required.
Cybersecurity documentation is often where regulated software reviews get stuck
For SaMD and regulated software, reviewers need more than a point-in-time vulnerability scan. They need evidence that application security work is repeatable, documented and tied to how software changes over time.
Regulated teams do not just need security activity. They need documentation that shows the process was followed.
- 01PLANNED
Every code change is tied to a tracked work item, with a clear record of what was created, and why.
- 02TESTED
Security scans show the change was tested before release. Results are recorded and tied to the code.
- 03APPROVED
Changes are reviewed and approved by someone other than the author.
- 04TRACEABLE
Changes move through separate environments, with evidence showing control across release stages.
- 01PLANNED
Every code change is tied to a tracked work item, with a clear record of what was created, and why.
- 02TESTED
Security scans show the change was tested before release. Results are recorded and tied to the code.
- 03APPROVED
Changes are reviewed and approved by someone other than the author.
- 04TRACEABLE
Changes move through separate environments, with evidence showing control across release stages.
- 01PLANNED
Every code change is tied to a tracked work item, with a clear record of what was created, and why.
- 02TESTED
Security scans show the change was tested before release. Results are recorded and tied to the code.
- 03APPROVED
Changes are reviewed and approved by someone other than the author.
- 04TRACEABLE
Changes move through separate environments, with evidence showing control across release stages.
From application security activity to FDA / SaMD cybersecurity documentation
Eureka connects application security activity across scans, fixes, releases and decisions so regulated teams can show what was found, how it was handled and what evidence exists before review.
Connect your repos and scanners
Aggregate source control, scanner output, and workflow activity into one unified view.
Organize findings for FDA review
See which application security findings affect your submissions and what needs to be addressed.
Track remediation through your workflow
Follow fixes from discovery through review, validation, and documented decision-making.
Convert activity into structured evidence
Turn development activity into cybersecurity documentation reviewers can follow.
Eureka supports the application security and cybersecurity documentation side of FDA / SaMD review. It does not replace regulatory consultants, auditors or the submission process.
Each stage adds to the cybersecurity record
As application findings move through the workflow, Eureka helps document what was mapped, fixed, validated, approved and exported, so the record reflects how the work actually happened.
Control-aligned findings
Findings linked to the components, controls, and releases they affect.
Documentation your team controls. Evidence others can follow
Security expertise built into the workflow, so teams can operate with a clearer regulatory process from day one.
Eureka helps your team capture, organize and export application security activity as cybersecurity documentation. Your team stays in control of what is shown, exported and stood behind.
Built for regulated software teams that need evidence, not another report
Capture cybersecurity documentation as work happens,
not during FDA / SaMD submission week.
Show every decision
Show how application security findings were handled across software changes, releases, and reviews.
Connect every review
Keep findings, remediation activity, and ownership connected in one workflow.
Control every approval
Organize application security evidence around controls, ASVS categories, and review needs.
Support every submission
Export structured cybersecurity documentation your team can review before submission.
Eureka supports cybersecurity documentation and helps document application security activity. It does not certify FDA readiness, guarantee submission acceptance, or replace regulatory consultants, auditors or GRC tooling.
Frequently asked questions.
No. Eureka does not certify readiness or guarantee submission acceptance. It helps teams organize the AppSec and cybersecurity workflow evidence that may support regulated software review.
Eureka can organize evidence around findings, affected components, remediation, validation, approvals, release history, and decisions connected to application security work.
A scan shows what was found at one moment. Regulated reviews may require a traceable process showing how issues were mapped, fixed, validated, approved, and documented over time.
Eureka keeps findings, remediation activity, validation, approval, and decision history connected to releases so teams can show how AppSec work changed across versions.
Yes. Eureka supports the AppSec evidence layer beneath those processes. Regulatory consultants, auditors, and GRC systems remain responsible for the broader submission or compliance workflow.
Before submission week. The strongest record is captured as engineering work happens rather than reconstructed later from screenshots, exports, and old tickets.
Do not wait until submission week to rebuild the evidence.
Turn application security activity into cybersecurity documentation your team can review, export and stand behind.