{ "transcriptFile": "Client_T761_Eakin_Tech_File_SW_Weekly_checkin.docx", "expected": { "meetingType": "Technical file review", "meetingTitle": "T761 Eakin Healthcare Tech File SW review - SW coding changes", "meetingPurpose": "Review T761 Eakin software coding changes and related technical-file dependencies for alarms, languages, versioning, electrical safety and cybersecurity.", "meetingObjectives": [ "Review completed alarm sound, colour and flash changes.", "Confirm remaining mute-button and clinical-review actions.", "Plan debug-command and code-review work.", "Track language-change and software-versioning dependencies.", "Confirm electrical compliance testing approach and timeline.", "Review cybersecurity risks and mitigation options." ], "executiveSummary": "The meeting reviewed software changes for the Eakin technical file, with alarm changes largely completed and language changes underway. Remaining work included mute-button behaviour, clinical review, debug testing, traceability for the 17 historic software changes, and possible retrospective test data. Electrical compliance testing will be completed in-house, while cybersecurity discussion focused on USB-port and GUI controls, including whether physical locks, software controls or benefit-risk rationale are appropriate.", "overallTopicsDiscussed": [ "Alarm code changes", "Mute button LED behaviour", "Clinical and usability review", "Alarm code review", "Debug commands", "Software versioning", "Change request", "Language capacity and font limitations", "Electrical compliance testing", "IEC 60601-1 gap review", "Cybersecurity controls", "USB port lock", "GUI security", "Benefit-risk analysis", "Standards 81001-5-1 and 27427" ], "discussion": [ "Andrew has implemented and demonstrated alarm sound changes for low, medium and high priority alarms.", "Low, medium and high priority alarm visuals have been updated with colour and LED flash behaviour.", "The remaining alarm question is what happens to the LED flashing behaviour when the mute button is pressed.", "A clinician mini-review of the audible alarm changes has been pushed to next week because clinical staff are unavailable.", "Feedback from clinicians and Adil may determine whether a longer-term usability update is needed.", "David wants to confirm which debug commands are physically visible or effective before test scripts are written.", "The software change request has been submitted and is expected to be reviewed on Wednesday.", "The change request covers alarm code changes, language changes and the retrospective software version change from 1.01 to 1.02.", "A further software release will be needed after the change request work is complete.", "The change is expected to be treated as non-significant or non-substantial through the regulatory process.", "The 17 historic software changes from version 1.01 to 1.02 need a gap assessment to confirm what changed and whether they are visible in code.", "If the 17 changes are not all battery-related, additional explanation or retrospective test data may be needed for traceability.", "Electrical compliance testing is being brought in-house and is expected to complete by around 23 July in the conservative timeline.", "Andrew has started reviewing the 60601-1 compliance document and identifying possible test gaps.", "The additional language work can load 18 language files, but Arabic, Vietnamese and Greek may require character or font support.", "Cybersecurity and risk discussion covered USB port access, screen access, unauthorised interference, therapy-mode changes and whether a lock, password or benefit-risk rationale is appropriate.", "Password protection may introduce clinical usability risk if clinicians need to intervene quickly.", "Risk scoring for third-party interference may have high severity in neonatal scenarios but low occurrence based on field experience.", "Rebecca is updating the risk management file and has purchased standards that may inform cybersecurity and nebuliser-port assessment.", "Fan logic and PMS/risk-management plan updates were also reviewed as part of the technical-file follow-up." ], "actions": [ { "owner": "Andrew", "action": "Confirm what happens to the alarm LED flashing behaviour when the mute button is pressed." }, { "owner": "Rebecca and clinical team", "action": "Complete the clinician mini-review of the alarm sound changes next week, including any usability input from Adil." }, { "owner": "David", "action": "Send or agree further debug commands for Andrew to test against the software." }, { "owner": "Andrew", "action": "Test the additional debug commands and confirm what is physically visible or produced on screen." }, { "owner": "Rebecca", "action": "Progress the submitted change request through the Wednesday review and gather the required close-out information." }, { "owner": "David", "action": "Complete the gap assessment of the 17 changes from software version 1.01 to 1.02 and identify where they are visible in the code." }, { "owner": "Rebecca", "action": "Incorporate David's output on the 17 software changes into the design-change or technical-file summary." }, { "owner": "Andrew", "action": "Continue the electrical compliance testing review and flag any support needed from David." }, { "owner": "Andrew", "action": "Continue the additional-language update, including character or font support for Arabic, Vietnamese and Greek, and load the translated files." }, { "owner": "Rebecca", "action": "Update the risk management file with USB port and screen-interference risks and proposed controls by Wednesday." }, { "owner": "Andrew", "action": "Review David's fan-logic document and decide whether it needs to be added to Cognidocs." }, { "owner": "Rebecca", "action": "Email the purchased standards, including 81001-5-1 and 27427, for assessment." }, { "owner": "Jacqui", "action": "Follow up with Colm to review whether the 27427 standard is applicable." }, { "owner": "Jacqui", "action": "Add Rebecca to the regular Tuesday follow-up call." } ], "humanGeneratedMinutes": { "files": [ { "label": "Human generated minutes", "file": "human_generated_minutes.pdf" } ], "meetingTitle": "T761 Eakin Healthcare Tech File SW review - SW coding changes", "meetingDate": "15 June 2026", "objective": [ "Alarm changes", "Language changes", "SW versioning changes", "Electrical safety testing and timeframe dependency", "Cybersecurity", "Document tracking", "SW workstream timeline delay" ], "minutesDiscussion": [ "Andrew completed the sound, screen-colour and flash changes for low, medium and high priority alarms with no issues noted.", "There was uncertainty around alarm mute button LED behaviour because the existing setup changes flash behaviour when muted.", "Clinical review of the code changes was pushed to the following week and should include nursing and usability input from Adil.", "David should review the new alarm code once it is complete.", "Andrew advised that the audio debug menu does not appear on the display screen, and Andrew and David need to connect on debug test scripts.", "David is reviewing the code to identify the 17 Marturion-listed changes from version 1.01 to 1.02 and provide traceability.", "If the 17 changes cannot be clearly identified in code, retrospective test data may need to be generated.", "One change request has been raised to document alarms, languages and the retrospective version 1.01 to 1.02 update.", "The change request is due for internal review in the week ending 19 June.", "Andrew replicated and uploaded 12 languages, proving memory capacity is available.", "Driver and font limitations may affect symbols for languages such as Greek, Arabic and Vietnamese.", "David suggested updating the graphics display driver to include additional fonts.", "Andrew and Rebecca confirmed electrical compliance testing will be completed in-house, with no UL requirement.", "Electrical compliance testing is planned for completion by 23 July.", "Andrew is reviewing IEC 60601-1 compliance documents against previous MDD documentation to capture testing gaps.", "Rebecca and Andrew are evaluating USB-port security options, including physical port locks and software controls.", "Cybersecurity risk discussion included unauthorised software overwrite, incorrect therapy settings, neonatal-patient harm scenarios, alarms, physical limits and password protection.", "If residual risk remains high after controls, a benefit-risk analysis may justify not adding usability-impacting controls such as password protection.", "Rebecca purchased standards 81001-5-1 and 27427 for review by Colm and Andrew." ], "minutesActions": [ { "owner": "Andrew", "action": "Review the mute button flash sequence against the existing setup.", "deadline": "19 June 2026" }, { "owner": "Rebecca", "action": "Complete clinical review of the code changes for sounds, colour and flash.", "deadline": "26 June 2026" }, { "owner": "Andrew and Rebecca", "action": "Sign off the change request.", "deadline": "22 June 2026" }, { "owner": "Andrew and David", "action": "Review the debug commands in the debug screen.", "deadline": "22 June 2026" }, { "owner": "Andrew", "action": "Review the graphics driver as a possible solution for uploading language symbols.", "deadline": "22 June 2026" }, { "owner": "Andrew", "action": "Review IEC 60601-1 against MDD documentation and outline the electrical compliance testing needed.", "deadline": "26 June 2026" }, { "owner": "Andrew", "action": "Complete electrical compliance testing.", "deadline": "23 July 2026" }, { "owner": "David", "action": "Trace software to identify changes between version 1.01 and version 1.02 and document the findings.", "deadline": "22 June 2026" }, { "owner": "David and Andrew", "action": "Generate retrospective test data if software changes cannot be seen.", "deadline": "30 June 2026" }, { "owner": "Rebecca", "action": "Update the risk management file addressing USB port lock and GUI security controls, including competitor-control review.", "deadline": "22 June 2026" }, { "owner": "Rebecca", "action": "Share standards 81001-5-1 and 27427 for review.", "deadline": "16 June 2026" }, { "owner": "Colm", "action": "Review relevance of the shared standards.", "deadline": "22 June 2026" } ] } } }