{"api":{"name":"api.sb","description":"Business-as-Code surface for Startups.Studio","home":"https://api.sb","docs":"https://api.sb/docs","version":"1.0.0"},"$context":"https://api.sb/$context","$type":"FoundingHypothesis","$id":"https://api.sb/founding-hypotheses/fh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1","links":{"self":"https://api.sb/v1/founding-hypotheses/fh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1","canonical":"https://api.sb/founding-hypotheses/fh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1","pool":"https://api.sb/v1/founding-hypotheses"},"foundingHypothesis":{"id":"fh:w2-compliance-audit-regulatory-affairs-mgr-regulatory-map:t-ais-prem:v1","lens":"ManagedWorkflow","type":"founding-hypothesis","click":{"rubricScores":{"C8_lensFit":0,"C7_magicLensFit":1,"C4_competitorHonesty":1,"C6_crossSlotCoherence":1,"C1_customerSpecificity":1,"C2_problemFrictionRealism":1,"C9_killCriteriaAttestability":1,"C3_approachEngineCoverability":1,"C5_differentiationLoservilleEscape":1},"upperRightLoserville":true},"cellRef":{"id":"work-contexts.org.ai/w2-compliance-audit-regulatory-affairs-mgr-regulatory-map","stableHash":"wcc:regulatory-affairs-mgr:compliance-audit:regulatory-map:v1"},"problem":{"slotStatement":"RA Managers maintain the regulatory map — the living matrix of which product SKUs are cleared under which regulation, standard, and notified-body file — in brittle Excel workbooks that drift from Master Control/Greenlight Guru QMS records, so every notified-body or FDA inspection burns 3–6 weeks reconciling SKU-to-regulation-to-evidence linkages by hand under audit pressure."},"approach":{"oneSentence":"A regulatory-map binder service that reconciles SKU-to-regulation-to-evidence rows against the QMS system of record and certifies each cell with a review-ready citation trace to the underlying 510(k), Technical File, or standard clause."},"customer":{"icpShape":"Regulatory Affairs Managers at US-headquartered medtech and in-vitro-diagnostic manufacturers ($250M–$2B revenue) navigating overlapping FDA QSR, EU MDR/IVDR, and Health Canada obligations, where the buyer is the VP Regulatory Affairs & Quality (PO signer) and the daily user is the Regulatory Affairs Manager maintaining the regulatory map.","beachheadShape":"EarlyAdopterJTBD: Class II/III medtech RA teams preparing for MDR re-certification audits in the next 9 months"},"archetype":"startup-archetypes.org.ai/ManagedWorkflow-OutcomeBased","beachhead":"EarlyAdopterJTBD: Class II/III medtech RA teams preparing for MDR re-certification audits in the next 9 months","competitors":{"substitutes":[{"name":"Excel regulatory matrix maintained by the RA team","category":"status-quo"},{"name":"MasterControl / Greenlight Guru QMS regulatory modules","category":"incumbent"},{"name":"RegDesk / Rimsys regulatory intelligence platforms","category":"adjacent vertical"},{"name":"Harvey / Hebbia horizontal legal-AI copilots","category":"AI-native horizontal"}]},"studioThesis":"T-AIS-PREM","killThreshold":{"K":8,"M":30,"N":7,"rubricItemSet":["C1_customerSpecificity","C2_problemFrictionRealism","C3_approachEngineCoverability","C4_competitorHonesty","C5_differentiationLoservilleEscape","C6_crossSlotCoherence","C7_magicLensFit","C8_lensFit","C9_killCriteriaAttestability"],"verdictPolicy":"all-load-bearing-pass-and-overall-ge-X","loadBearingItemSet":["C1_customerSpecificity","C2_problemFrictionRealism","C3_approachEngineCoverability","C4_competitorHonesty","C5_differentiationLoservilleEscape","C6_crossSlotCoherence","C9_killCriteriaAttestability"],"verdictPolicyVerbatim":"KILL unless every load-bearing rubric item passes per workbook AND overall pass-rate ≥ 7/9 (CASCADE.md §4 Stage 9 commit threshold)."},"lifecycleState":"Active","differentiation":{"twoByTwo":{"xAxis":"Evidence trace depth (free-text regulatory claim ↔ cell-level citation to the exact 510(k) page, MDR Annex clause, or harmonized standard section)","yAxis":"Regulatory scope breadth (single-jurisdiction template ↔ cross-jurisdiction SKU × regulation × notified-body matrix maintained as the system of record)","winningQuadrant":"cell-level primary-source citations across a live cross-jurisdiction SKU×regulation matrix that a notified-body auditor can open and verify in place","loservilleEscape":true,"loservilleQuadrant":"Rimsys-style single-jurisdiction intelligence feeds and Harvey-style horizontal chat that summarize regulations but leave the SKU-to-evidence linkage as untraced free text the RA Manager must re-verify by hand"}},"unmetRequirements":[],"pricingArchitecture":"usage-meter"},"actions":{},"options":{},"relationships":{"runtimeUnit":"https://api.sb/v1/runtime-units?startupRef=startup%3Afh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1","brand":"https://api.sb/v1/brands?startupId=startup%3Afh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1","listing":"https://api.services/listings?foundingHypothesisRef=fh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1","cell":"https://api.sb/v1/cells/work-contexts.org.ai/w2-compliance-audit-regulatory-affairs-mgr-regulatory-map","thesis":"https://api.sb/v1/theses/T-AIS-PREM"},"meta":{"level":"L0","scopes":[]},"user":{"requestId":"a057bbc5da102308","edgeLocation":"a057bbc5da102308","geo":{"country":"US"},"ua":{"browser":"Claude"}},"references":{"total":0,"limit":25,"page":1,"links":{"self":"https://api.sb/v1/founding-hypotheses/fh%3Aw2-compliance-audit-regulatory-affairs-mgr-regulatory-map%3At-ais-prem%3Av1/references"},"items":[]}}