BSI Round-1 Submission: Export Plan

Overview

This plan identifies every document to export as PDF and upload to the BSI staging area on Google Drive before the round-1 response is submitted. Documents are grouped by category. Each entry lists the source file path, its change status relative to the first submission, and any export-specific notes.

Upload destination: BSI round-1 staging folder

---

Document Queue

Risk Management

Doc code	File	Status	Notes
R-TF-013-002	apps/qms/docs/legit-health-plus-version-1-1-0-0/risk-management/R-TF-013-002-Risk-Management-Record.mdx	Unchanged	BSI Item 7 mistook a separate AI preliminary analysis document for this record. Export as-is to demonstrate that the actual risk record already covers AI risks affecting patients in full compliance with the R-TF-013 procedure.
R-TF-013-003	apps/qms/docs/legit-health-plus-version-1-1-0-0/risk-management/R-TF-013-003-Risk-Management-Report.mdx	Updated	Further explanation added per Item 7 response. See change notes below.

Clinical Evaluation

Doc code	File	Status
R-TF-015-001	apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-001-Clinical-Evaluation-Plan.mdx	Major update
R-TF-015-003	apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-003-Clinical-Evaluation-Report.mdx	Major update
R-TF-015-011	apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-011-State-of-the-Art.mdx	Major update

Clinical Investigations (CIP + CIR for each evidence study)

Export R-TF-015-004 (CIP) and R-TF-015-006 (CIR) for all ten investigations cited as evidence in the CEP. All ten CIPs and CIRs were updated during the BSI review process.

Study identifier	Folder	CIP path	CIR path	Evidence type
MC_EVCDAO_2019	mc-evcdao-2019	…/mc-evcdao-2019/r-tf-015-004.mdx	…/mc-evcdao-2019/r-tf-015-006.mdx	Pillar 3, Rank 2 (melanoma classification)
COVIDX_EVCDAO_2022	covidx-evcdao-2022	…/covidx-evcdao-2022/r-tf-015-004.mdx	…/covidx-evcdao-2022/r-tf-015-006.mdx	Pillar 3, Rank 2
DAO_Derivación_O_2022	dao-derivacion-o-2022	…/dao-derivacion-o-2022/r-tf-015-004.mdx	…/dao-derivacion-o-2022/r-tf-015-006.mdx	Pillar 3, Rank 2 (dermatology triage via ophthalmology)
DAO_Derivación_PH_2022	dao-derivacion-ph-2022	…/dao-derivacion-ph-2022/r-tf-015-004.mdx	…/dao-derivacion-ph-2022/r-tf-015-006.mdx	Pillar 3, Rank 4 (primary health)
IDEI_2023	idei-2023	…/idei-2023/r-tf-015-004.mdx	…/idei-2023/r-tf-015-006.mdx	Pillar 3, Rank 2 prospective / Rank 4 retrospective
AIHS4_2025	aihs4-csp-2025	…/aihs4-csp-2025/r-tf-015-004.mdx	…/aihs4-csp-2025/r-tf-015-006.mdx	Severity proof-of-concept (HS, M-27134-01 trial)
BI_2024	bi-2024	…/bi-2024/r-tf-015-004.mdx	…/bi-2024/r-tf-015-006.mdx	Pillar 3, Rank 11 MRMC (rare pustular dermatoses + HS)
PH_2024	ph-2024	…/ph-2024/r-tf-015-004.mdx	…/ph-2024/r-tf-015-006.mdx	Pillar 3, Rank 11 MRMC (primary care referral decision-making)
SAN_2024	san-2024	…/san-2024/r-tf-015-004.mdx	…/san-2024/r-tf-015-006.mdx	Pillar 3, Rank 11 MRMC (general diagnostic accuracy)
MAN_2025	man-2025	…/man-2025/r-tf-015-004.mdx	…/man-2025/r-tf-015-006.mdx	Pillar 3, Rank 11 MRMC (Fitzpatrick V–VI) — new study, not in first submission

Base path prefix for all investigation files: apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Investigation/

Post-Market Surveillance

Doc code	File	Status
R-TF-007-001	apps/qms/docs/legit-health-plus-version-1-1-0-0/post-market-surveillance/R-TF-007-001-Post-Market-Surveillance-PMS-Plan.mdx	Updated
R-TF-007-002	apps/qms/docs/legit-health-plus-version-1-1-0-0/post-market-surveillance/R-TF-007-002-Post-Market-Clinical-Follow-up-PMCF-Plan.mdx	Updated

PMCF Clinical Investigation Plans (CIP only — no CIR)

Export the R-TF-015-004 (CIP) for each specific PMCF activity listed in the PMCF Plan (R-TF-007-002). These are planned post-market studies — no CIR exists yet because they have not started or completed. BSI needs the CIPs to verify that each PMCF activity is backed by a formal investigation protocol aligned with ISO 14155:2020, as required by MDR Annex XIV Part B.

Activity	Study code / folder	CIP path	PMCF gap addressed
A.1	VH_triaje_2025	…/VH_triaje_2025/r-tf-015-004.mdx	Gap 1 — triage and malignancy prioritisation
A.2	Sant_Pau_2024	…/Sant_Pau_2024/r-tf-015-004.mdx	Gap 1 — melanoma follow-up prioritisation
A.3	VH_clinical_2025	…/VH_clinical_2025/r-tf-015-004.mdx	Gap 1 — primary care triage pilot
B.1	AFF_2026	…/AFF_2026/r-tf-015-004.mdx	Gap 2 — FFA severity (5RB)
B.2	ALADIN_2026	…/ALADIN_2026/r-tf-015-004.mdx	Gap 2 — acne severity (5RB)
B.3	aEASI_HVN_2026	…/aEASI_HVN_2026/r-tf-015-004.mdx	Gap 2 — atopic dermatitis EASI (5RB)
B.4	AVASI_2026	…/AVASI_2026/r-tf-015-004.mdx	Gap 2 — vitiligo AVASI (5RB)
B.5	AIHS4_2026	…/AIHS4_2026/r-tf-015-004.mdx	Gap 2 — HS confirmatory (5RB)
C.1	ICD_DXP_2026	…/ICD_DXP_2026/r-tf-015-004.mdx	Gap 3 — core diagnostic performance monitoring
C.2	Legit.Health-US-version-1-1-0-0	…/Legit.Health-US-version-1-1-0-0/r-tf-015-004.mdx	Gap 3 — FDA pivotal (C.2.1, C.2.2, C.2.3 share one CIP)

Base path prefix: apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Investigation/

Activities D.1 (PMCF-AutoImmune-Coverage-2026) and D.2 (PMCF-Genodermatoses-Surveillance-2026) are passive-surveillance activities governed directly by the PMCF Plan and do not have a separate CIP document listed; they are not included in this export batch.

---

What Changed

Two new pieces of evidence integrated since the first submission

These two items were incomplete at the time of the original submission and have now been fully integrated into the CEP and CER.

MAN_2025 MRMC (Fitzpatrick V–VI): Simulated-use multi-reader multi-case study on Fitzpatrick phototype V and VI presentations. Added as the tenth pivotal investigation (Pillar 3, Rank 11). Data lock: 17 April 2026; primary-analysis cohort: 16 participants. Full CIP/CIR/Annex E pass performed. The CEP, CER, and PMCF Plan now reference it explicitly alongside the three earlier MRMC studies.

Legacy RWE study conclusions (R-TF-015-012): The post-market observational study for the legacy predecessor device had not yet produced final conclusions at the time of the first submission. Those conclusions are now integrated into the CEP evidence portfolio, the CER, and routed into the PMS/PMCF Plans. The underlying R-TF-015-012 document itself is not exported in this batch — see Exclusions below.

R-TF-013-003 (Risk Management Report)

Further explanation added per the Item 7 response. The addition clarifies the distinction between the AI preliminary risk analysis (an internal engineering artifact) and the actual R-TF-013-002 risk record, which is the document that covers AI-related hazards affecting patients under the ISO 14971 procedure. BSI had confused the two.

R-TF-015-001 (Clinical Evaluation Plan)

• MAN_2025 integrated as the tenth pivotal study; Mermaid Clinical Development Plan diagram updated accordingly.
• R-TF-015-012 legacy observational study conclusions added to the evidence portfolio under the MDCG 2020-5 equivalence framework.
• Three-pillar causal-chain alignment per MDCG 2020-1, incorporating the external methodological review by Horiana (Céline Fabre, 2026-04-17).
• Rank-table rebuilt; pillar framing refined throughout.
• Phase-1 / Bucket-C cross-reference tightened.
• Surrogate-endpoint anchoring for Pillar 2 evidence.
• SME subspecialty coverage documented.
• IFU integration-requirements verification (task-3b14).
• §6.3 triangulation propagated from legacy PMS conclusions.

R-TF-015-003 (Clinical Evaluation Report)

• MAN_2025 per-study evidence block added.
• Development-data composition section added (Fitzpatrick phototype distribution, held-out internal-test stratified performance).
• All four MRMC studies consolidated at Rank 11, Pillar 3 per MDCG 2020-1 §4.4.
• Legacy RWE (R-TF-015-012) N=56 analysis-set corrections propagated throughout.
• Four-way review remediation pass: MRMC pillar framing, canonical investigation count, integrator mandate, Article 83 timing, Rank-8 fallback, threshold reconciliation to performanceClaims.ts.
• External methodological review (Horiana/Céline Fabre) integrated.
• Publication citations migrated to a canonical renderer backed by scientificPublicationsData.ts.
• §6.3 triangulation propagated.

R-TF-015-011 (State of the Art)

• PICO search algorithm overhauled for PubMed phrase-index compliance and Annex A5 reproducibility.
• Stream B manufacturer-specific keyword register added to R-TF-015-011 with a tightened CEP cross-reference.

Clinical Investigation CIPs and CIRs (all ten)

The table below summarises the scope of changes per study.

Study	Scope of changes
MC_EVCDAO_2019	Full CIP/CIR/Annex E rewrite — malignancy-as-primary endpoint, Pillar 3 Rank 2–4
COVIDX_EVCDAO_2022	Full CIP/CIR/Annex E rewrite — Pillar 3 §4.4 supporting at Rank 2–4, 4 of 7 pre-specified acceptance criteria met per performanceClaims.ts
DAO_Derivación_O_2022	Full CIP/CIR/Annex E rewrite — referral appropriateness as primary endpoint, Pillar 3 Rank 2–4
DAO_Derivación_PH_2022	Full CIP/CIR/Annex E rewrite — referral-adequacy endpoint, source-of-truth reconciliation to performanceClaims.ts
IDEI_2023	Full CIP/CIR/Annex E rewrite — Pillar 3 primary at Rank 2–4, malignancy-as-primary, honest Ludwig-agreement non-attainment documented
AIHS4_2025	IFU integration-requirements verified; safety-confirmation cross-cut applied
BI_2024	Full CIP/CIR/Annex E rewrite — Pillar 3 §4.4 at Rank 11
PH_2024	Pillar 3 §4.4 framing added to CIP; adequacy-review fixes applied
SAN_2024	Pillar 3 §4.4 at Rank 11 reclassification (previously framed as Pillar 2)
MAN_2025	Full CIP/CIR/Annex E pass; data refresh (19 enrolled / 16 primary-analysis / 17 April 2026 data lock)

R-TF-007-001 (PMS Plan)

Legacy PMS (R-TF-015-012) conclusions routed in; §6.3 triangulation propagated.

R-TF-007-002 (PMCF Plan)

§6.3 triangulation propagated; legacy PMS conclusions integrated (Erin Q5 closure).

---

Exclusions

Do not export anything from apps/qms/docs/legit-health-version-2-1/post-market-surveillance/, including:

• r-tf-015-012-legacy-pms-cross-sectional-study-protocol.mdx
• r-tf-015-012-legacy-pms-cross-sectional-study-report.mdx
• r-tf-007-003-legacy-pms-report.mdx
• r-tf-007-005-legacy-pms-plan.mdx

These are cited as evidence in the CER (R-TF-015-012 as Rank 4 supplementary post-market RWE) but we are not sending them proactively. Submit only if BSI specifically requests the underlying legacy PMS documents.

---

Export Instructions

1. Pull latest main and run npm run build:qms to confirm there are no build errors.
2. Use /export-pdf qms with the specific route for each document listed above. The QMS app routes follow the folder hierarchy under docs/, e.g.:
   • legit-health-plus-version-1-1-0-0/risk-management/R-TF-013-002-Risk-Management-Record
   • legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-001-Clinical-Evaluation-Plan
   • legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Investigation/man-2025/r-tf-015-004
3. Name every exported PDF as {record code} {document title}.pdf, matching exactly how the document is cited in the BSI responses (e.g. R-TF-015-001 Clinical Evaluation Plan). For study-specific CIPs and CIRs, append the study code after -: {record code} {document title} - {study code}.pdf. Use ASCII-only characters throughout — no accented characters. Full reference list:
   • R-TF-013-002 Risk Management Record.pdf
   • R-TF-013-003 Risk Management Report.pdf
   • R-TF-015-001 Clinical Evaluation Plan.pdf
   • R-TF-015-003 Clinical Evaluation Report.pdf
   • R-TF-015-011 State of the Art.pdf
   • R-TF-007-001 Post-Market Surveillance (PMS) Plan.pdf
   • R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan.pdf
   • R-TF-015-004 Clinical Investigation Plan - MAN_2025.pdf
   • R-TF-015-006 Clinical Investigation Report - MAN_2025.pdf
   • R-TF-015-004 Clinical Investigation Plan - DAO_Derivacion_O_2022.pdf (drop accent in filename; accent is fine in the PDF cover title)
4. Upload all PDFs to the staging folder: https://drive.google.com/drive/folders/1-4umiz957--Oo3qCP07THY3jCsCaX1Br
5. Verify the folder contains 37 PDFs total before closing out:
   • 2 risk management documents
   • 3 clinical evaluation documents
   • 20 investigation documents (10 CIPs + 10 CIRs — evidence studies)
   • 2 post-market surveillance documents
   • 10 PMCF CIPs (planned post-market studies, CIP only)

---

Export Status

Run 1 — 2026-04-21

Uploaded: 35 of 37 PDFs to the staging folder https://drive.google.com/drive/folders/1-4umiz957--Oo3qCP07THY3jCsCaX1Br.

All documents exported reflect the latest main branch at the time of export (commit 49f149e85). Each PDF was generated from a fresh build of the QMS app with printer-safe typography, headings-as-bookmarks, and branded cover page. Filenames follow the ASCII-only convention defined in the Export Instructions above.

Breakdown of what was uploaded:

• 2 of 2 risk management documents
• 3 of 3 clinical evaluation documents
• 20 of 20 investigation documents (10 CIPs + 10 CIRs — evidence studies)
• 2 of 2 post-market surveillance documents
• 8 of 10 PMCF CIPs
• 1 additional — Instructions for Use (EU MDR).pdf (current EN version 1.1.0.0, merged single PDF, 120 pages)
• 6 additional procedures — GP-004 Vigilance system.pdf, GP-006 Non-conformity, Corrective and Preventive actions.pdf, GP-007 Post-market surveillance.pdf, GP-014 Feedback and complaints.pdf, GP-016 Traceability and identification.pdf, GP-020 QMS Data analysis.pdf (each exported as the procedure index page only; Templates/specific-procedures child pages excluded)

Outstanding — 2 PMCF CIPs not yet exportable

The following two PMCF CIPs are listed in the PMCF Plan (R-TF-007-002) but do not yet have a Clinical Investigation Plan document (r-tf-015-004.mdx) in the technical file, so they could not be exported in Run 1:

Activity	Study code	Gap	Blocker
B.5	AIHS4_2026	Gap 2 — HS confirmatory (5RB)	No AIHS4_2026/ folder exists under the Investigation directory. Only the 2025 investigator-initiated precursor (aihs4-csp-2025) has a CIP; the 2026 confirmatory CIP is TBD.
C.2	Legit.Health-US-version-1-1-0-0	Gap 3 — FDA pivotal (C.2.1, C.2.2, C.2.3 share one CIP)	The folder exists in the US technical file but contains only FDA_510k_Clinical_Strategy_Status.mdx and a description file. No r-tf-015-004.mdx CIP document has been authored.

These two CIPs must be authored before a follow-up export can bring the staging folder to 37 PDFs. Both are planned post-market studies governed by the PMCF Plan; the CIP documents themselves are the remaining deliverable.