Solutions
Carbon is for teams building regulated software — not for marketing sites, not for unregulated internal tools, not for anyone unwilling to sit five gates.
New 510(k), an FDA finding, ISO 13485 recertification. IEC 62304, ISO 14971, 21 CFR Part 820/11. Documentation is the critical path and it is still written last.
Carbon generates the package. It does not replace your ALM or your notified-body relationship.
HIPAA security-rule audits, BAA requirements, M&A diligence. Evidence collected in week 12 is how deals slip.
SOC 2, PCI-DSS re-scope, SOX, bank vendor questionnaires. The questionnaire is the product until it is answered with sourced evidence.
FedRAMP ATO, CJIS, ITAR/EAR, Section 508. Authorization packages assembled by hand still take quarters. Carbon’s job is the documentation generation those platforms do not do.
EU AI Act, ISO 42001, NIST AI RMF. Governance mandates are arriving faster than documentation teams. Carbon treats those as framework cues that shape artifacts — not as a full production-model monitoring platform.
New product submission
Generate the package from scratch for FDA, FedRAMP, SOC 2, and peers.
Certification maintenance
Keep documentation current between recertification cycles so the next audit is not a sprint.
Security questionnaires
Evidence packages for buyers who will not sign until you are security-ready.
M&A diligence
Assemble a clean, sourced set when the clock is set by someone else’s deal.