Change Orders
Execute and track formal change implementations.
1
DRAFT
1
IN PROGRESS
1
IN REVIEW
0
RELEASED
0
CANCELLED
| CO ID | Title | Linked CR | Status | Created | |
|---|---|---|---|---|---|
| CO-BF12EC31 | CO: HA-1000 firmware v4.2 deployment Phase 1: V&V per IEC 62304. Phase 2: Cybersecurity assessment (SaMD). Phase 3: Field deployment plan for 340 installed units. Phase 4: Customer notification. | CR-29F6F1F5 | IN REVIEW | 3/10/2026 | |
| CO-21787E9C | CO: RGT-500 shelf life extension validation Execute 24-month real-time stability study. Update IFU with new expiry dating. Notify distributors of labeling change. | CR-56A0B2EC | DRAFT | 3/10/2026 | |
| CO-C48D027E | CO: IVDR Class C transition project Phase 1: Gap analysis vs IVDR Annex II/III. Phase 2: Engage notified body (BSI). Phase 3: Update technical file. Phase 4: Clinical performance re-evaluation. Timeline: 9 months. | CR-36A42325 | IN PROGRESS | 3/10/2026 |