Master Dossier — EquiTrak Pro
CE Mark
ISO 13485
Class IIb
47%
documents verified by human
Total Documents
17
12 received, 3 partial, 2 missing
AI Verified
11
confidence avg 93%
Human Verified
8
Critical Gaps
2
red
| Document | Status | Source | AI Type | Version | Expiry | AI Confidence | AI Summary | Actions |
|---|---|---|---|---|---|---|---|---|
| Technical Documentation | received | Manufacturer | Technical File | v4.2 | N/A | 97% | Comprehensive 847-page technical file covering design, manufacturing, testing. | |
| Design & Manufacturing Evidence | received | Manufacturer | Design Dossier | Rev 3 | N/A | 91% | Design history file and manufacturing process. Includes ISO 14971 risk management. | |
| Software Documentation | partial | Manufacturer | IEC 62304 Software File | v2.1 | N/A | 85% | Software lifecycle documentation partial — missing v3.0 update from Q4 2025. | |
| ISO 13485 Certificate | received | BSI Group | QMS Certificate | 2016 | Dec 2027 | 99% | Full scope ISO 13485:2016 from BSI. Valid December 2027. No conditions. | |
| CE Certificate | received | TÜV Rheinland | CE Certificate | Class IIb | Mar 2026 ⚠️ | 98% | ⚠️ CE Mark expires March 2026 — CRITICAL. Renewal application should be in progress now. | |
| Declaration of Conformity | received | AudioTech GmbH | DoC | 2024 Ed. | N/A | 94% | DoC references 14 applicable harmonised standards. Signed by CEO. Current version. | |
| Clinical Evaluation Report | received | Manufacturer | CER | v5.0 | N/A | 93% | CER v5.0 covers 14 clinical studies (n=2,847). Meets MEDDEV 2.7/1 Rev 4. | |
| India Pilot Study Report | received | AIIMS Delhi | Clinical Study | 2023 | N/A | 96% | India-specific pilot: 42 patients at AIIMS Delhi. 89% success rate. CDSCO-relevant. | |
| Post-Market Clinical Follow-Up | received | Manufacturer | PMCF Plan | 2025 | N/A | 89% | PMCF plan active with annual report cycle. Last report January 2026. | |
| Biocompatibility Report (ISO 10993) | received | TÜV | Biocompat. Report | 2022 | N/A | 95% | Full ISO 10993 series. All 12 endpoints pass. No biological hazards. | |
| EMC Test Report | received | SGS Germany | EMC Report | 2023 | N/A | 92% | EMC per IEC 60601-1-2 Ed 4. All markets covered. | |
| Sterilization Validation | missing | — | — | — | — | 0% | ||
| IFU (English) | received | Manufacturer | IFU English | Rev 7 | N/A | 97% | English IFU complete with surgical technique guide. Meets EU MDR Annex I. | |
| IFU — Hindi Translation | missing | — | — | — | — | 0% | ||
| IFU — Arabic Translation | partial | Partial draft | IFU Arabic | — | — | 72% | Arabic IFU 60% complete. Surgical procedure section not yet translated. | |
| FDA 510(k) Clearance | received | US FDA | 510(k) | K231456 | N/A | 99% | Active FDA clearance. Valid indefinitely unless device substantially changed. | |
| Free Sale Certificate | partial | Manufacturer | FSC | 2024 | Dec 2025 ⚠️ | 86% | FSC expired December 2025. Renewal needed. Required for India, UAE, Bangladesh. |
AI Advisor
CE Mark expiry (March 2026) is the most critical gap — if not renewed, all CE-based approvals become void. Sterilization Validation is missing and will be required by CDSCO. Hindi and Arabic IFU translations are blocking India and UAE submissions respectively.