# Meeting Minutes

## Metadata

| | |
|---|---|
| Organisation | Not stated |
| Reference | Not stated |
| Meeting | T733/T817 Eakin Healthcare Consultancy Retainer - Client project checkin for TF24 |
| Date | Not stated |
| Duration | Not stated |
| Attendees |  |

## Objectives

Review TF24 technical-file remediation status and agree next actions across risk, software, subcontractors, usability, testing and PMS.

## Executive Summary

The TF24 weekly check-in reviewed progress against the technical-file remediation tracker. Key priorities remained risk/software, subcontractors and usability. Software alarm changes were largely complete but needed mute-button, clinical and usability review; language changes and versioning work remained in progress; and electrical compliance testing would now be completed in-house. The meeting also covered risk management, cybersecurity, subcontractor justifications, usability study planning, process maps, marketing, accelerated testing, biocomp, PMS comments and the TF03 MDR findings submission.

## Key Discussion Points

| Topic | Discussion | Outcome |
|---|---|---|
| Topic 1 | The tracker has moved positively, with fewer documents in the 20 to 39 percent completion band. | See discussion |
| Topic 2 | The main technical-file priorities remain risk and software. | See discussion |
| Topic 3 | Cybersecurity updates are needed because of USB ports on the back of the CPAP machine. | See discussion |
| Topic 4 | Rebecca is updating the risk management plan and matrix, including more detail on FMEAs across software, hardware and related areas. | See discussion |
| Topic 5 | Andrew has progressed alarm-related software changes across sound, flash and colour. | See discussion |
| Topic 6 | The remaining alarm issue is how the mute button affects the flash sequence. | See discussion |
| Topic 7 | Clinical review with Janine and Adil is needed to confirm whether the alarm changes are acceptable in the field. | See discussion |
| Topic 8 | The alarm changes are expected to be handled through a change request review. | See discussion |
| Topic 9 | The firmware appears to have capacity for the 12 additional languages. | See discussion |
| Topic 10 | Arabic, Vietnamese and Greek may need symbol or font support before the translated GUI files can be fully loaded. | See discussion |
| Topic 11 | The alarm and language updates will produce a new software version. | See discussion |
| Topic 12 | The new software version should also document the retrospective update from version 1.01 to 1.02. | See discussion |
| Topic 13 | David is tracing the 17 historical software changes from version 1.01 to 1.02 and identifying any test-scenario gaps. | See discussion |
| Topic 14 | Retrospective test scenarios may be needed where changes cannot be supported from existing traceability. | See discussion |
| Topic 15 | Electrical compliance testing will be completed in-house and is expected to finish in the second-last week of July. | See discussion |
| Topic 16 | Subcontractor documentation is mostly available, with missing items to be handled through justifications or further actions. | See discussion |
| Topic 17 | Formative usability study timing is expected to fall after the initial August submission but before notified body review. | See discussion |
| Topic 18 | Task analysis is mostly complete and Adil is planning how to execute the study. | See discussion |
| Topic 19 | Operational process maps and procedures are awaiting finalisation with Christina. | See discussion |
| Topic 20 | PMS comments from David need to feed into the relevant summary or PMS documentation. | See discussion |

## Actions

| Owner | Action | Due |
|---|---|---|
| Rebecca | Update the risk management plan and matrix, including the cybersecurity and FMEA detail. | Not stated |
| David | Review Rebecca's updated risk-management wording and confirm it is on the right lines. | Not stated |
| Andrew | Confirm the mute-button flash behaviour and progress the clinical review of the alarm changes with Janine and Adil. | Not stated |
| Andrew | Resolve symbol or font issues for Arabic, Vietnamese and Greek so the translated language files can be loaded. | Not stated |
| David | Trace the 17 software changes from version 1.01 to 1.02 and identify where retrospective test scenarios are needed. | Not stated |
| Andrew | Work through the in-house electrical compliance testing so outputs are available for David's final software and technical-file deliverables. | Not stated |
| Rebecca | Work through subcontractor documentation gaps and agree any justifications or further actions with Louise. | Not stated |
| Adil | Plan execution of the formative usability study and align the timing with the MDR submission and notified body review window. | Not stated |
| Kevin and Christina | Finalise the operational process maps and procedures once Christina returns. | Not stated |
| Ciaran | Review David's PMS comments and incorporate them into the relevant PMS or summary documentation. | Not stated |