Cross-reference updates required by the legacy-PMS hierarchy refactor
This file tracks every cross-reference that needs editing when task-3b10 lands. Each entry names the file, the section, the current text, and the target text. Updates are applied in a single pass to keep the build green.
1. Filename renames
| Old file | New file |
|---|
apps/qms/docs/legit-health-version-2-1/post-market-surveillance/pms-study-protocol.mdx | apps/qms/docs/legit-health-version-2-1/post-market-surveillance/r-tf-015-012-legacy-pms-cross-sectional-study-protocol.mdx |
apps/qms/docs/legit-health-version-2-1/post-market-surveillance/pms-study-report.mdx | apps/qms/docs/legit-health-version-2-1/post-market-surveillance/r-tf-015-012-legacy-pms-cross-sectional-study-report.mdx |
apps/qms/docs/legit-health-version-2-1/post-market-surveillance/r-tf-007-003-pms-report.mdx | apps/qms/docs/legit-health-version-2-1/post-market-surveillance/r-tf-007-003-legacy-pms-report.mdx |
| (new file) | apps/qms/docs/legit-health-version-2-1/post-market-surveillance/r-tf-007-005-legacy-pms-plan.mdx |
All renames are performed with git mv so git tracks the history.
2. Audit-visible cross-references
2.1 R-TF-015-001 Clinical Evaluation Plan
| Section (approx. line) | Current text | Target text |
|---|
| §Regulatory pathway (line ~1014) | "the post-market observational study R-TF-015-012" | Unchanged — R-number is stable. |
| §Planned evidence classification per study (line ~1094) | Row: "R-TF-015-012 (legacy device post-market observational study)" | Row unchanged; description updated to "Cross-sectional observational study nested inside the legacy umbrella PMS Plan (R-TF-007-005); the study Protocol is held as R-TF-015-012, its Report as Appendix D to R-TF-015-012, and its conclusions are consolidated in the legacy umbrella PMS Report (R-TF-007-003)." |
| §Evidence quality hierarchy — Rank 7 bullet (line ~1036) | "consolidated in the legacy device PMS Report (R-TF-007-003)" | Unchanged — R-number stable. |
| §Phased progression / mermaid Phase 4 block (line ~919) | Node "R-TF-015-012: Cross-sectional observational study (Rank 4 + Rank 8)" | Unchanged — R-number stable. |
2.2 R-TF-015-003 Clinical Evaluation Report
| Section | Current text | Target text |
|---|
| §Legacy-device PMS subsection opening (line ~1645) | "aggregated in the legacy-device PMS Report (R-TF-007-003, legacy version). The aggregate has been appraised..." | "aggregated in the legacy-device umbrella PMS Report (R-TF-007-003), planned under the paired umbrella PMS Plan (R-TF-007-005). The aggregate has been appraised..." |
| §Post-market clinical study subsection (line ~1651) | "a proactive post-market clinical study of the equivalent legacy device was conducted under a formal PMS Study Protocol (R-TF-015-012)" | "a proactive post-market clinical study of the equivalent legacy device was conducted under a formal study Protocol (R-TF-015-012) nested within the legacy umbrella PMS Plan (R-TF-007-005)" |
| §Post-market clinical study — safety data (line ~1701) | "Full thematic analysis... are documented in the legacy device PMS Report (R-TF-007-003)" | "Full thematic analysis... are documented in the legacy umbrella PMS Report (R-TF-007-003)" |
| §Per-study appraisal — R-TF-015-012 header (line ~1096) | "R-TF-015-012: Post-market cross-sectional observational study of the equivalent legacy device" | Unchanged. Role-statement sentence added to the subsection opening: "This study sits at the study-specific tier of the legacy post-market documentation hierarchy, nested inside the umbrella PMS Plan (R-TF-007-005) and the umbrella PMS Report (R-TF-007-003)." |
2.3 Other audit-visible documents that mention R-TF-007-003 or R-TF-015-012
| File | Action |
|---|
legit-health-plus-version-1-1-0-0/overview-and-device-description/r-tf-sted.mdx | No change required — refers to R-TF-007-003 by R-number only. |
legit-health-plus-version-1-1-0-0/risk-management/R-TF-013-003-Risk-Management-Report.mdx | No change required — refers to R-TF-007-003 by R-number only. |
legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Investigation/agm-2026/r-tf-015-004.mdx | Review; likely no change. |
legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Investigation/dao-derivacion-ph-2022/r-tf-015-006.mdx | Review; likely no change. |
procedures/GP-015/index.mdx | Review; likely no change. |
legit-health-plus-version-1-1-0-0/post-market-surveillance/deprecated/* | No change — deprecated folder, not shipped. |
Strategy: updates are R-number-anchored. Any reference that already uses R-TF-007-003 or R-TF-015-012 by R-number keeps working unchanged after rename. The only reason to touch those files is to add the umbrella-Plan R-TF-007-005 citation where it is logically required (primarily in R-TF-015-001 CEP and R-TF-015-003 CER).
3. Internal (BSI-response / research) references
3.1 BSI responses
| File | Edit |
|---|
bsi-non-conformities/clinical-review/round-1/item-3-clinical-data/rb-data-sufficiency-justification/response.mdx | Update two passages that name "the PMS Study Protocol (R-TF-015-012)" to "the study Protocol (R-TF-015-012) nested within the legacy umbrella PMS Plan (R-TF-007-005)". Keep reviewer-friendly language — no file paths. |
bsi-non-conformities/clinical-review/round-1/item-3-clinical-data/ra-clinical-data-analysis/research-and-planning.mdx | Internal doc — update once during the sweep; no reviewer-friendly constraint. |
bsi-non-conformities/clinical-review/round-1/item-3-clinical-data/message-for-saray.mdx | Internal doc — optional update. |
bsi-non-conformities/clinical-review/round-1/item-5-pms-plan/research-and-planning.mdx | Internal doc — add a note that the umbrella Plan is R-TF-007-005 and the umbrella Report is R-TF-007-003. |
bsi-non-conformities/clinical-review/round-1/item-6-pmcf-plan/rb-pmcf-data-sufficiency-justification/research-and-planning.mdx | Internal doc — optional update. |
bsi-non-conformities/clinical-review/round-1/item-6-pmcf-plan/ra-pmcf-activity-descriptions/research-and-planning.mdx | Internal doc — optional update. |
bsi-non-conformities/clinical-review/round-1/item-7-risk/response.mdx | Review mentions; keep R-number-anchored. |
bsi-non-conformities/clinical-review/round-1/item-7-risk/research-and-planning.mdx | Internal doc — optional update. |
3.2 Task-3b2-3b3 CLAUDE.md
The "Canonical deliverables" table needs updating:
| Old row | New row |
|---|
PMS Study Protocol (R-TF-015-012) → pms-study-protocol | Study-specific Protocol (R-TF-015-012) → r-tf-015-012-legacy-pms-cross-sectional-study-protocol |
PMS Study Report (Appendix D) → pms-study-report | Study-specific Report (Appendix D to R-TF-015-012) → r-tf-015-012-legacy-pms-cross-sectional-study-report |
Legacy device PMS Report, MDR Article 85 (R-TF-007-003) → r-tf-007-003-pms-report | Legacy umbrella PMS Report (R-TF-007-003) → r-tf-007-003-legacy-pms-report |
| (new row) | Legacy umbrella PMS Plan (R-TF-007-005) → r-tf-007-005-legacy-pms-plan |
3.3 Task folders that mention the legacy files by path
| File | Edit |
|---|
task-3b5-autoimmune-genodermatoses-triangulation/index.md and CLAUDE.md | Internal — update once. |
task-3b6-surrogate-endpoint-literature-review/CLAUDE.md | Internal — update once. |
task-3b7-icd-per-epidemiological-group-vv/CLAUDE.md | Internal — update once. |
task-3b8-safety-confirmation-column-definition/CLAUDE.md | Internal — update once; coordinate since task-3b8 lands after 3b10. |
task-3b9-legacy-pms-conclusions-into-plus-pms-plan/CLAUDE.md | Internal — update once; already anchored to R-numbers, minor filename tweaks. |
resources/_celines-feedback/*.md | Internal — update once. |
adequacy-review/*.md | Internal — update any path-based links. |
round-1/index.mdx | Review; update if paths are mentioned. |
3.4 Source code
Search under apps/qms/src for any hardcoded path to the two renamed files. Update any React component that links to them. If none found, this step is a no-op.
4. Build validation
After all edits:
npm run build from repo root — catches dead sidebar links and missing pages.npx turbo run start --filter=qms — spot-check the four refactored documents in the rendered sidebar.npm run lint format — no functional impact but keeps the tree clean.