Every device change has a compliance cascade. See yours before you submit.
For medical device manufacturers, IVD, and digital health (SaMD) teams: the Impact Intelligence Verification Graph Engine (VGE) traverses your operational graph to surface impacts across:
- Design History Files and design verification/validation protocols
- IQ/OQ/PQ records and process validation chains
- Supplier qualifications and clinical evidence
- Regulatory submissions (510(k), PMA, CE marking)
Preview mode lets you ask 'what if?' before committing - with cost-of-change estimates and uncertainty bands.
DHF change impact map
Surface every impacted artifact across your device portfolio before approvals:
- Design History Files and design inputs/outputs
- Validation protocols (design verification, IQ/OQ/PQ)
- Supplier qualifications and regulatory submissions
Validation protocol cascade
Generate re-execution plans without committing changes:
- Design verification/validation and IQ/OQ/PQ re-execution scope
- Biocompatibility retest requirements
- Clinical evidence gap analyses
Regulatory submission impact
Determine regulatory scope and cost impact:
- New 510(k) scope (Traditional, Special, Abbreviated)
- QMS document updates under QMSR/ISO 13485
- Notified body review effort with uncertainty bands (min/likely/max)
Console preview
Change intelligence report
Seed change
Device specification change: Catheter wall thickness 0.035″ → 0.028″
Change impact
73 of 380 nodes (19%)
across 6 domains
Severity hotspots
6
critical
NRE estimate
$124K – $268K
likely $187K
Schedule delta
+45d
critical path
Impact cascade / sample path
DHF biocompatibility spec - device master record DMR-CTH-2200-B
via dhf
4 DV/DV protocols require re-execution
via validation
510(k) determination triggered for 2 devices
via regulatory
3 supplier biocompatibility certs invalidated
via procurement
8 clinical evidence chains affected
via clinical
1 other active device changes overlap this DHF scope
- └─ DCR-1187 Luer connector material change - biocompatibility retest 7 shared nodes under review
Verification pack / draft
- 4 DV/DV protocol re-executions
- 3 supplier re-qualifications
- 2 regulatory submission updates
- 8 clinical evidence reviews
Cost estimate: NRE $124K – $268K (likely $187K) · Recurring +$2.40/unit
- ├─ Design verification testing: $42K – $68K (biocompatibility + mechanical)
- ├─ DHF update and 510(k) amendment: $28K – $45K (regulatory submission revision)
- ├─ WIP scrap risk: 1,200 units at $18/unit if wall thickness fails burst test
- ├─ Schedule penalty: +45d delays product release by 1 regulatory cycle
- ├─ Recurring: +$2.40/unit from tighter extrusion tolerance spec
The problem
Device change impact analysis lives in audit findings - not in your change control process.
A supplier proposes a component substitution. Your quality engineer says 'just a simple DHF revision.' Six weeks later, you discover it invalidated 3 validation protocols (design verification and IQ/OQ/PQ), requires a new 510(k) for 2 impacted devices, impacts 8 clinical evidence chains, and the validation cost is 12x the original estimate.
Hidden cost of blind changes
- Invalidated validation protocols discovered during FDA inspection - not before DHF approval.
- Clinical evidence chains broken by device specification changes nobody tracked.
- Supplier qualification lapses affecting 12 device lines with no advance warning.
- QMS document update costs off by an order of magnitude because DHF dependencies were invisible.
Key capabilities
Active intelligence for healthcare changes.
DHF dependency mapping
Walk multi-level Design History Files to surface every impacted specification, test protocol, supplier qualification, and regulatory submission across your full device portfolio.
Validation cascade analysis
Trace design verification/validation and IQ/OQ/PQ protocol dependencies through device specifications, clinical pathways, and quality plans to reveal the full re-validation scope before execution begins.
Regulatory submission triggers
Detect when a device or process change requires a new 510(k) determination per 21 CFR 807.81(a)(3), triggers QMS document updates under QMSR/ISO 13485, or affects clinical evidence packages - and generate submission task lists with evidence requirements.
Clinical evidence impact preview
Identify every clinical pathway, outcome data chain, and evidence package affected by a proposed change, with patient safety severity scoring and revalidation recommendations.
Supplier qualification propagation
Map which supplier qualifications, incoming inspection plans, and biocompatibility certifications are invalidated by a change, before production discovers the gap.
Validation cost delta estimation
Calculate IQ/OQ/PQ re-execution hours, clinical retest scope, and regulatory submission costs with uncertainty ranges that calibrate from your actual validation time entries.
UDI traceability dependency check
Verify whether device configuration changes affect UDI identifiers, labeling requirements, or GUDID submissions across product families.
Compliance evidence assembly
Assemble audit-ready DHF packages from existing records, highlight missing artifacts, and track sign-off status across impacted nodes, validation requirements, proof paths, and clinical evidence chains.
How it works
From change signal to verified action.
Seed the change
A ChangeControl record identifies what's changing: device specification, clinical workflow modification, supplier substitution, or regulatory requirement update.
Traverse the graph
Domain providers walk the dependency graph across DHFs, validation protocols, supplier qualifications, clinical pathways, evidence chains, and regulatory submissions.
Score severity
Each impacted node receives a severity score (0.0–1.0) based on patient safety implications, regulatory weight, re-validation complexity, and submission status.
Detect collisions
Cross-change collision detection reveals when concurrent device modifications or protocol revisions create overlapping validation requirements that require triage.
Generate verification packs
Assemble design verification/validation re-execution plans, IQ/OQ/PQ protocols, supplier re-qualification tasks, clinical evidence updates, and DHF revision packages from existing records - preview them before committing.
Estimate validation cost
Validation hours, clinical retest scope, regulatory submission fees, and schedule impact computed with min/likely/max uncertainty bands.
Act or iterate
Apply the change with idempotency keys to persist verification packs, or adjust parameters and re-run the analysis in preview mode.
Hybrid graph model
VGE traverses your existing healthcare operational schema with no data migration required. The engine analyzes dependencies across DHFs, validation protocols, clinical pathways, and regulatory records.
Virtual edges
Inferred dependencies from DHF structures, device configurations, IQ/OQ/PQ protocol hierarchies, and clinical pathway relationships.
Explicit edges
Tenant-defined dependencies with rationale and supporting context, e.g., linking a biocompatibility cert to specific DHF revisions or clinical evidence to patient cohorts.
Policy edges
Rules mapping regulatory frameworks (FDA QMSR incorporating ISO 13485:2016, ISO 14971) to required validation work for each change type and device classification.
Healthcare impact scenarios
Real change scenarios in healthcare.
Impact Intelligence adapts to your domain’s change patterns, compliance frameworks, and verification workflows. These are representative output examples from the VGE computation pipeline.
Healthcare
Cost: $187K (range: $124K–$268K) · 4 protocols re-executedTrigger
Device specification change
Impact
DHF revisions across 3 product families, 4 validation protocols invalidated (DV and IQ/OQ/PQ), 2 supplier qualifications require re-audit, new 510(k) determination required for 1 device.
Verification Pack
Updated DHF package, DV/IQ/OQ/PQ re-execution plan, supplier re-qualification schedule, new 510(k) submission evidence bundle.
Metrics
Cost: $187K (range: $124K–$268K) · 4 protocols re-executed
Healthcare
Schedule: +24 days · 5 pathways affectedTrigger
Clinical workflow modification
Impact
5 care pathway evidence chains affected, 12 clinical outcome datasets require revalidation, 3 training records outdated, 2 site SOPs impacted.
Verification Pack
Pathway validation report, outcome data gap analysis, updated training acknowledgements, SOP revision package.
Metrics
Schedule: +24 days · 5 pathways affected
Healthcare
Cost: $143K (range: $98K–$201K) · 8 device lines affectedTrigger
Supplier qualification change
Impact
Alternate source cascade across 8 device lines, incoming inspection protocol updates, 6 biocompatibility certificates require retest, DHF impact across 4 families.
Verification Pack
Supplier audit pack, incoming inspection updates, biocompatibility retest plan, DHF revision schedule.
Metrics
Cost: $143K (range: $98K–$201K) · 8 device lines affected
Healthcare
11 DHFs revised · Schedule: +31 daysTrigger
Regulatory requirement update (FDA/ISO)
Impact
11 DHF sections require revision, 6 validation protocols need gap closure, 3 regulatory submissions impacted, 2 clinical evidence packages need supplementation.
Verification Pack
DHF gap analysis, protocol update plan, new 510(k) determination checklist, clinical evidence supplement.
Metrics
11 DHFs revised · Schedule: +31 days
Healthcare
15 documents revised · 7 training modules updatedTrigger
Quality system revision (QMSR / ISO 13485)
Impact
Process FMEA updates across 4 device families, 7 training modules require revision, 15 controlled documents cascade, 3 management review records affected.
Verification Pack
FMEA update pack, training plan with competency assessments, document revision queue, management review evidence.
Metrics
15 documents revised · 7 training modules updated
Impact Intelligence for Healthcare
Operational scale that makes impact analysis possible.
VGE runs on tenant-owned data: schema depth, API breadth, and deterministic telemetry that keeps change reviews consistent.
Domain providers
15+
5 cross-industry baseline + 10 domain-specific providers (composition structures, compliance, verification, 3D/geometric, procurement, inventory, capital assets, execution chains), each self-describing with SemVer and cost tiers.
Sync analysis
≤2s
Typical graph traversal (≤1K nodes) with batch-first providers and per-request caching.
Async analysis
≤30s
Complex traversals (≤10K nodes) with optional Redis acceleration and per-provider timing.
Impact demo
Impact Intelligence for Healthcare
Preview change impact, severity scoring, and verification packs before approvals.
Change impact
73 nodes
Projected change
Severity hotspots
6
Projected change
NRE estimate
$187K
Projected change
Schedule delta
+45d
Projected change
Sample finding
Surface every impacted artifact across your device portfolio before approvals:
Impact cascade
Seed the change
Virtual edges
Explicit edges
Policy edges
API preview
Schema-stable endpoints for impact intelligence.
Impact Intelligence is designed as a tenant-owned API surface with preview-first semantics, deterministic run snapshots, and export-ready results.
Preview vs apply
Every request can run in preview mode to generate impact results without mutating data. Apply mode uses idempotency keys to persist verification packs safely.
View developer docsPOST Start impact analysis
Seed a new analysis for a device specification change, supplier substitution, or clinical workflow modification. Preview mode is the default.
POST /api/v1/change-controls/{id}/impact/runThe ChangeControl record (created separately) carries the change details: material biocompatibility revision for catheter assembly CTH-2200-B, Lot L2026-0041 through L2026-0087, replacing silicone elastomer grade BIO-4401-C with BIO-4401-E per updated ISO 10993-5 cytotoxicity data.
Request
{
"detect_collisions": true
}Response
{
"schema_version": "vge.graph_result.v1",
"run_id": 524,
"nodes": [
{
"node_ref": {
"resource_type": "dhf_section",
"resource_id": 2200301,
"display_name": "DHF-2200 §4.3 - Material Biocompatibility Specification",
"display_code": "DHF-2200-4.3",
"status": "Revision Required",
"tags": [
"Class II",
"ISO 10993-5",
"CTH-2200-B"
]
},
"severity": 0.94,
"depth": 1
},
{
"node_ref": {
"resource_type": "validation_protocol",
"resource_id": 2200501,
"display_name": "OQ-2200-007 - Biocompatibility Acceptance Criteria",
"display_code": "OQ-2200-007",
"status": "Re-execution Required",
"tags": [
"OQ",
"ISO 10993",
"cytotoxicity"
]
},
"severity": 0.91,
"depth": 2
},
{
"node_ref": {
"resource_type": "regulatory_submission",
"resource_id": 2200801,
"display_name": "510(k) K241872 - Predicate Device Comparison, §8 Materials",
"display_code": "K241872-S8",
"status": "New 510(k) Determination Required",
"tags": [
"FDA",
"Special 510(k) candidate",
"substantial equivalence"
]
},
"severity": 0.96,
"depth": 2
},
{
"node_ref": {
"resource_type": "supplier_qualification",
"resource_id": 2200601,
"display_name": "SUP-3391 - Biocompatibility Certificate, BIO-4401-E",
"display_code": "SQ-3391-BIO",
"status": "Qualification Pending",
"tags": [
"ISO 13485 §7.4",
"incoming inspection",
"elastomer"
]
},
"severity": 0.85,
"depth": 3
}
],
"edges": [
{
"source": {
"resource_type": "dhf_section",
"display_code": "DHF-2200-4.3"
},
"target": {
"resource_type": "device_master_record",
"display_code": "DMR-CTH-2200-B"
},
"edge_type": "IMPLEMENTED_IN",
"provider": "dhf",
"label": "DHF biocompatibility spec implemented in device master record DMR-CTH-2200-B"
},
{
"source": {
"resource_type": "dhf_section",
"display_code": "DHF-2200-4.3"
},
"target": {
"resource_type": "validation_protocol",
"display_code": "OQ-2200-007"
},
"edge_type": "VALIDATED_BY",
"provider": "validation",
"label": "Biocompatibility spec validated by OQ protocol - ISO 10993-5 cytotoxicity"
},
{
"source": {
"resource_type": "dhf_section",
"display_code": "DHF-2200-4.3"
},
"target": {
"resource_type": "regulatory_submission",
"display_code": "K241872-S8"
},
"edge_type": "REFERENCED_BY",
"provider": "regulatory",
"label": "510(k) §8 references biocompatibility data for substantial equivalence"
}
],
"stats": {
"node_count": 73,
"edge_count": 134,
"provider_counts": {
"dhf": 28,
"validation": 19,
"regulatory": 12,
"supplier_quality": 8,
"clinical_evidence": 6
},
"truncated": false,
"collisions": {
"collision_count": 0,
"collision_severity": "NONE"
}
}
}GET Retrieve change impact
Get the full impact graph with severity scores, DHF depth, affected validation protocols, and regulatory submission triggers.
GET /api/v1/change-controls/{id}/impactGET Trace proof path
Explain why a specific validation protocol, DHF section, or clinical evidence chain is impacted, auditable at every dependency hop.
GET /api/v1/change-controls/{id}/impact/explain?node_key=regulatory_submission:2200801:headResponse
{
"run_id": 524,
"target_node_key": "regulatory_submission:2200801:head",
"path_node_keys": [
"dhf_section:2200301:head",
"device_master_record:2200:head",
"regulatory_submission:2200801:head"
],
"path_edges": [
{
"edge_type": "IMPLEMENTED_IN",
"provider": "dhf",
"label": "DHF-2200-4.3 biocompatibility specification implemented in device master record DMR-CTH-2200-B"
},
{
"edge_type": "REFERENCED_BY",
"provider": "regulatory",
"label": "510(k) K241872 §8 references biocompatibility data from DHF-2200-4.3 - material change BIO-4401-C → BIO-4401-E requires substantial equivalence re-evaluation"
}
],
"notes": "2-hop path: DHF biocompatibility section → device master record → 510(k) submission. Material grade change requires updated ISO 10993-5 cytotoxicity data and may trigger a new 510(k) (Special 510(k) if eligible) per 21 CFR 807.81(a)(3)."
}GET Detect cross-change collisions
Find where concurrent device modifications create overlapping validation requirements on shared DHF nodes.
GET /api/v1/change-controls/{id}/impact/collisionsResponse
{
"collision_count": 2,
"colliding_change_ids": [
519,
531
],
"collision_severity": "HIGH",
"top_overlapping_nodes": [
{
"node_key": "validation_protocol:2200501:head",
"severity": 0.91,
"change_ids": [
524,
519
],
"display": "OQ-2200-007 Biocompatibility Acceptance - overlaps with CC-519 (sterilization process change affecting ISO 10993-7 EO residuals)"
},
{
"node_key": "dhf_section:2200301:head",
"severity": 0.88,
"change_ids": [
524,
531
],
"display": "DHF-2200 §4.3 Material Biocompatibility - overlaps with CC-531 (CAPA-0298 corrective action on extractables testing)"
}
]
}POST Generate verification pack
Generate IQ/OQ/PQ re-execution plans, supplier re-qualification tasks, and clinical evidence updates in preview or apply mode.
POST /api/v1/change-controls/{id}/verification-pack/generateRequest
{
"mode": "preview"
}Response
{
"proposed_validations": [
{
"validation_type": "inspection",
"validation_meta": {
"description": "OQ-2200-007 re-execution - biocompatibility acceptance criteria updated for BIO-4401-E per ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization, and ISO 10993-23 irritation requirements",
"affected_nodes": [
"validation_protocol:2200501:head",
"validation_protocol:2200502:head"
],
"protocols": [
"OQ-2200-007 (Biocompatibility Acceptance)",
"PQ-2200-012 (Finished Device Bioburden)"
]
}
},
{
"validation_type": "document_review",
"validation_meta": {
"description": "510(k) K241872 - new 510(k) determination required (Special 510(k) candidate). §8 Materials section requires updated substantial equivalence comparison for BIO-4401-E elastomer grade",
"affected_nodes": [
"regulatory_submission:2200801:head"
],
"regulatory_basis": "21 CFR 807.81(a)(3) - significant change in materials"
}
},
{
"validation_type": "inspection",
"validation_meta": {
"description": "SUP-3391 incoming inspection plan update - add BIO-4401-E certificate of analysis acceptance criteria, biocompatibility lot release testing per ISO 13485 §7.4.3",
"affected_nodes": [
"supplier_qualification:2200601:head"
]
}
},
{
"validation_type": "checklist",
"validation_meta": {
"description": "DHF-2200 revision - update §4.3 material spec, §5.1 risk analysis (ISO 14971), §6.2 biocompatibility test reports, and device master record DMR-CTH-2200-B",
"affected_nodes": [
"dhf_section:2200301:head",
"dhf_section:2200302:head",
"dhf_section:2200303:head"
]
}
}
],
"proposed_external_acknowledgements": [
{
"target_type": "SUPPLIER",
"target_id": 3391,
"reason": "Material grade change BIO-4401-C → BIO-4401-E requires updated Certificate of Analysis and biocompatibility lot release data"
},
{
"target_type": "NOTIFIED_BODY",
"target_id": 7100,
"reason": "ISO 13485 certificate scope review - material biocompatibility change on Class II device may require surveillance audit update"
}
]
}POST Estimate validation cost
Estimate NRE costs (device reconfiguration, protocol updates, documentation revisions) and recurring impact (per-unit validation cost changes, added clinical verification steps) with min/likely/max uncertainty bounds.
POST /api/v1/change-controls/{id}/cost-estimateResponse
{
"estimate_id": 1087,
"impact_analysis_run_id": 524,
"line_items": [
{
"cost_driver_type": "nre",
"description": "OQ/PQ re-execution - biocompatibility acceptance (OQ-2200-007) and finished device bioburden (PQ-2200-012), 6 test runs across Lots L2026-0041 through L2026-0087",
"quantity": 6,
"unit_rate": 14200,
"cost_phase": "nre",
"min_cost": 68000,
"likely_cost": 85200,
"max_cost": 118000,
"confidence": 0.85
},
{
"cost_driver_type": "nre",
"description": "New 510(k) submission for K241872 (Special 510(k)) - updated substantial equivalence for BIO-4401-E, §8 materials and biocompatibility summary, eSTAR preparation",
"quantity": 1,
"unit_rate": 42000,
"cost_phase": "nre",
"min_cost": 32000,
"likely_cost": 42000,
"max_cost": 58000,
"confidence": 0.72
},
{
"cost_driver_type": "nre",
"description": "DHF-2200 revision - §4.3 material spec, §5.1 risk analysis, §6.2 biocompatibility reports, device master record DMR-CTH-2200-B",
"quantity": 4,
"unit_rate": 8500,
"cost_phase": "nre",
"min_cost": 26000,
"likely_cost": 34000,
"max_cost": 48000,
"confidence": 0.88
},
{
"cost_driver_type": "nre",
"description": "SUP-3391 re-qualification - incoming inspection update, CoA acceptance criteria for BIO-4401-E, biocompatibility lot release protocol",
"quantity": 1,
"unit_rate": 18500,
"cost_phase": "nre",
"min_cost": 14000,
"likely_cost": 18500,
"max_cost": 26000,
"confidence": 0.78
},
{
"cost_driver_type": "nre",
"description": "ISO 14971 risk analysis update - biocompatibility hazard re-evaluation, DFMEA revision, clinical risk-benefit update",
"quantity": 48,
"unit_rate": 155,
"cost_phase": "nre",
"min_cost": 5800,
"likely_cost": 7440,
"max_cost": 10200,
"confidence": 0.84
},
{
"cost_driver_type": "recurring",
"description": "Per-lot biocompatibility release testing - additional ISO 10993-5 cytotoxicity screening for BIO-4401-E incoming lots",
"quantity": 1,
"unit_rate": 340,
"cost_phase": "recurring",
"min_cost": 280,
"likely_cost": 340,
"max_cost": 425,
"confidence": 0.91,
"justification": "Third-party lab quote for ISO 10993-5 cytotoxicity panel: $340/lot vs $0 for previously qualified BIO-4401-C"
}
],
"nre_range": {
"min": 145800,
"likely": 187140,
"max": 260200
},
"recurring_range": {
"min": 280,
"likely": 340,
"max": 425,
"currency": "USD",
"description": "Per-lot recurring cost increase from added biocompatibility release testing for BIO-4401-E"
},
"schedule_impact": {
"min_schedule_days": 32,
"likely_schedule_days": 45,
"max_schedule_days": 68,
"critical_path_nodes": [
"regulatory_submission:2200801:head"
]
},
"confidence": 0.81,
"confidence_notes": "Estimate calibrated from your operational data. FDA 510(k) review timeline is the primary uncertainty driver (MDUFA goal varies by pathway); OQ/PQ re-execution lab availability is secondary.",
"justification_summary": "Material biocompatibility change BIO-4401-C → BIO-4401-E drives $187K NRE (OQ/PQ re-execution across 6 validation runs, new 510(k) submission for K241872, DHF-2200 revision package, supplier re-qualification, ISO 14971 risk analysis update) plus $340/lot recurring biocompatibility release testing. FDA 510(k) review is the critical path."
}GET Export impact graph
Export the full impact graph as JSON, CSV, or GraphML for integration with eQMS systems or regulatory portals.
GET /api/v1/impact-analysis-runs/{run_id}/export?format=graphmlPreview endpoints reflect the planned VGE surface. Final routes may adjust as the engine deploys to production.
FAQ
Common questions about Impact Intelligence for healthcare.
How does VGE handle multi-level DHF dependencies?
VGE traverses the full Design History File hierarchy. Depth is configurable per analysis run with regulatory context awareness.
Can Impact Intelligence preview validation cascades before DHF approval?
Yes. Preview mode is the default. Seed an analysis with your proposed device change and VGE computes the full IQ/OQ/PQ cascade, clinical evidence impact, regulatory submission scope, and validation cost estimate without persisting any changes. Iterate as many times as needed before approving.
What happens when a supplier qualification expires during production?
VGE detects the expiration as a change signal and computes the downstream impact: affected device lines, incoming inspection holds, biocompatibility certificate gaps, and DHF revision requirements. The resulting verification pack highlights re-qualification tasks with evidence requirements and regulatory rationale.
Does it integrate with our existing eQMS or regulatory submission systems?
Impact Intelligence runs on your EquatorOps operational data. Results export as JSON, CSV, or GraphML for integration with eQMS platforms (MasterControl, Veeva Vault), regulatory portals (eSTAR/CDRH Portal, Health Canada), and DHF management tools.
How are concurrent device changes detected?
Cross-change collision detection compares validation blast radii of all active and in-review device modifications. When overlapping DHF nodes, protocols, or clinical pathways are found, high-severity collisions automatically create triage queue entries with patient safety impact scores and evidence paths for human resolution.
Are validation cost estimates reliable for budget planning?
Validation cost estimates produce uncertainty ranges (min/likely/max) with confidence scores, not false precision. They calibrate from your actual data: IQ/OQ/PQ execution times, clinical retest durations, supplier audit costs, and historical validation outcomes.
Can we customize severity scoring for our regulatory framework?
Yes. Severity parameters are tenant-configurable to match your risk profile. Map them to your regulatory framework (FDA QMSR / ISO 13485, ISO 14971) and device classification (Class I/II/III) so scoring reflects your actual risk profile.
What about changes that affect UDI identifiers or GUDID submissions?
UDI providers traverse device configuration-to-identifier relationships, labeling requirements, and GUDID submission records. A device specification change surfaces every product family, UDI variant, and GUDID entry that requires update or re-submission.
How does Impact Intelligence handle new 510(k) determination?
When a device or process change meets the significance threshold under 21 CFR 807.81(a)(3), Impact Intelligence flags the affected regulatory submissions and determines whether a new 510(k) is required. The verification pack identifies the likely pathway - Traditional, Special, or Abbreviated - based on the change scope, and generates the submission task list with eSTAR preparation steps and substantial equivalence evidence requirements.
Does Impact Intelligence reflect the QMSR transition from legacy Part 820?
Yes. Policy edges reference FDA QMSR (21 CFR Part 820 incorporating ISO 13485:2016) rather than legacy QSR language. When a change triggers QMS document updates, Impact Intelligence maps the affected procedures, work instructions, and records against QMSR requirements and flags notified body review effort where applicable.