Technical Review: Round 1
N3 (Risk mitigation evidence) is blocked by two other NCs that must be answered first:
- M1 Q4 (T377 test results alignment): N3's mitigations 2 and 3 reference the AI Models Integration Tests (T307-T379), and M1 Q4 addresses the test evidence format for those same tests. N3 needs to cross-reference M1 Q4's explanation.
- M2 Q2 (Labeling/IFU requirements V&V): N3's mitigation 1 (IFU information about device outputs) relies on the labeling requirements verification chain that M2 Q2 establishes. N3 should reference M2 Q2's evidence rather than duplicating it.
M2 Q2 (Labeling/IFU requirements V&V) and N2 QC (IFU usability results) are not independent findings — they reflect the auditor systematically checking the complete V&V story for the IFU:
- M2 Q2 = Verification: Are the 26 labeling requirements (LR-XXXX) present and correct in the IFU/label? Content completeness via per-requirement review.
- N2 QC = Validation: Does the IFU actually work for users? Content effectiveness via usability testing (IEC 62366-1 §5.9).
M2 Q2 used the phrase "verified and/or validated." The verification part is addressed by per-requirement traceability in R-TF-001-006. The validation part is what N2 QC addresses — the auditor sees usability testing as the mechanism by which IFU validation is demonstrated. Both responses cross-reference each other (M2 Q2 cites R-TF-025-007 as validation evidence per EN 82304-1 §5.3; N2 QC cites R-TF-001-006 for content verification). Keep this alignment consistent.
Overview
This section documents the non-conformities raised by BSI during the Round 1 Technical Documentation Assessment for the device, version 1.1.0.0.
| Field | Value |
|---|---|
| Assessment reference | T0088560 |
| BSI job reference / SMO | 30365821 |
| Reviewer | Maggie Kusano (Technical Reviewer) |
| Round 1 sent | 2026-02-28 |
| Response deadline | 2026-03-17 |
| Status | In process |
Summary of non-conformities
This round contains 5 non-conformities: 2 major and 3 minor.
Major non-conformities
| Code | Topic | Questions | Key area |
|---|---|---|---|
| M1 | Diagnostic Function | 4 | IFU performance claims clarity, AI model integration verification test environment and results |
| M2 | Software V&V | 3 | Verification evidence for WAF/CCD requirements, labeling/IFU requirements V&V, HL7 FHIR verification |
Minor non-conformities
| Code | Topic | Questions | Key area |
|---|---|---|---|
| N1 | Information Supplied | 1 (2 sub-items) | GSPR 23 label compliance, eIFU link in installation instructions |
| N2 | Usability | 4 | EN 62366-1 summative evaluation gaps, 33% intended use misunderstanding |
| N3 | Risk Management | 1 | Risk mitigation implementation and verification evidence (R-DAG example) |
Response process
As per BSI's instructions:
- Responses must be written directly in BSI's Word document (
MDR 792790 - T0088560.docx) - Supplementary evidence should be compiled as a single bookmarked PDF
- Red-lined documentation should be provided for any document changes
- This review is limited to 3 rounds of questions per BSI policy
- Unresolved items at the end of all rounds will be identified as non-conformities in the technical documentation assessment report
Key documents referenced by BSI
The following documents from our technical file were reviewed by BSI and are referenced across the non-conformities:
| Document | Referenced in |
|---|---|
ifu.pdf (Instructions for Use) | M1, N1 |
master.csv (AI model integration verification test master) | M1 |
C515_T355/case-001/response.json | M1 |
C537_T377/case-001/response.json | M1 |
Software Requirements (R-TF-012-034) | M2, N3 |
Labeling and IFU Requirements (R-TF-012-037) | M2 |
waf_*.png (WAF test evidence) | M2 |
test_rail_verification_tests-...results.csv | M2 |
Summative Evaluation Reports (R-TF-025-004, R-TF-025-007) | N2 |
Risk Management Record (R-TF-013-002) | N2, N3 |
Applicable requirements
The non-conformities reference the following regulatory requirements and standards:
- MDR 2017/745 Annex I (General Safety and Performance Requirements: GSPRs): 1, 4, 5, 15.1, 17.2, 23
- MDR 2017/745 Annex II: 5(b), 6.1(a)(b), 6.2(f)
- EN 62304: Medical device software: Software life cycle processes
- EN 82304-1: Health software: General requirements for product safety
- EN 62366-1: Medical devices: Application of usability engineering to medical devices
- EN ISO 14971: Medical devices: Application of risk management to medical devices