# Meeting Minutes

## Metadata

| | |
|---|---|
| Organisation | Not stated |
| Reference | Not stated |
| Meeting | Client T761 Eakin SW - weekly checkin |
| Date | Not stated |
| Duration | Not stated |
| Attendees |  |

## Objectives

Follow up on T761 software technical-file risks, standards applicability, alarm change close-out, language updates and cybersecurity controls.

## Executive Summary

The team clarified several technical-file points for the T761 software workstream. David challenged the justification behind probability ratings, and the team agreed the software list could remain in Excel with explanatory context. The group considered standards applicability, especially 81001-5-1 and ISO 27427, reviewed the approved alarm change and clinical feedback, and tracked remaining language, debug, electrical testing and version-traceability work. Cybersecurity discussion focused on documenting a proportionate USB and GUI-control approach without creating clinical usability risk.

## Key Discussion Points

| Topic | Discussion | Outcome |
|---|---|---|
| Topic 1 | David queried how the probability-table numbers in the risk management plan are justified, including what one event represents. | See discussion |
| Topic 2 | Rebecca needs to add clarity to the risk rationale while updating the risk documentation. | See discussion |
| Topic 3 | The software list can remain in Excel, with a front page explaining the tabs and folder structure for the auditor. | See discussion |
| Topic 4 | The real-time clock battery alarm issue may already be covered in the risk analysis but should be checked. | See discussion |
| Topic 5 | IEC 81001-5-1 is not considered applicable to TF24 because IEC 62304 already covers the relevant medical device software lifecycle. | See discussion |
| Topic 6 | ISO 27427 applicability depends on whether the standard covers gas supplied to a nebulizer and whether FD140i's six-litre flow falls within scope. | See discussion |
| Topic 7 | The FD140i supplies flow to a connected nebulizer but does not itself nebulize. | See discussion |
| Topic 8 | The alarm mute-button behaviour has been reviewed, with a proposed approach where unmuted alarms show priority-specific flash behaviour and muted alarms use the familiar slow ramp. | See discussion |
| Topic 9 | The clinical team reviewed the alarm changes and considered them acceptable or an upgrade. | See discussion |
| Topic 10 | The alarm change request has been approved. | See discussion |
| Topic 11 | David still needs to provide debug command letters so Andrew can confirm what happens in the debug screen. | See discussion |
| Topic 12 | Five additional languages have been added, while the remaining languages need character or font-driver work. | See discussion |
| Topic 13 | Access to a font-creator tool is blocked by the firewall and has been raised with IT. | See discussion |
| Topic 14 | Andrew is part-way through the IEC 60601-1 versus MDD documentation review and the testing scope is still being defined. | See discussion |
| Topic 15 | Electrical compliance testing remains on track, with existing UL testing covering some of the reviewed areas. | See discussion |
| Topic 16 | David is prioritising traceability for the 17 software changes between versions 1.01 and 1.02. | See discussion |
| Topic 17 | If a software change has no visible code trace, retrospective test data may need to be generated. | See discussion |
| Topic 18 | Cybersecurity discussion focused on USB port access, GUI access, possible port locks, password controls and the risk of introducing usability delays. | See discussion |
| Topic 19 | A password may help software access control but could introduce clinical risk if it delays therapy changes. | See discussion |
| Topic 20 | Cybersecurity controls need to be documented clearly in the risk plan and matrix. | See discussion |

## Actions

| Owner | Action | Due |
|---|---|---|
| Rebecca | Add clarity to the risk management plan around probability-table number justification and what counts as an event. | Not stated |
| David | Add a front page to the software-list Excel explaining what each tab represents and the purpose of the file. | Not stated |
| Jacqui | Check whether the real-time clock battery alarm issue is captured in the risk analysis. | Not stated |
| Andrew | Confirm the nebulizer flow-rate specification so David and Colm can assess ISO 27427 applicability. | Not stated |
| David and Colm | Review ISO 27427 again once Andrew confirms the nebulizer flow-rate specification. | Not stated |
| David | Send additional debug command letters to Andrew. | Not stated |
| Andrew | Test the debug commands and report what happens on the debug screen. | Not stated |
| Andrew | Resolve the remaining language character and font-driver issues, including access to the font-creator tool. | Not stated |
| Andrew | Complete the IEC 60601-1 versus MDD documentation review and define the remaining electrical compliance testing. | Not stated |
| David | Review the alarm code changes and later repeat the review for the language-selection software changes. | Not stated |
| David | Prioritise tracing the 17 software changes from version 1.01 to 1.02 and identify any retrospective test-data needs. | Not stated |
| Rebecca | Update the risk files, plan and matrix with the agreed cybersecurity and USB-port-lock approach. | Not stated |