{ "transcriptFile": "Client_Eakin_T733_Consultancy_Retainer_Tech_File_review_weekly.docx", "expected": { "meetingType": "Technical file review", "meetingTitle": "T733/T817 Eakin Healthcare Consultancy Retainer - Client project checkin for TF24", "meetingPurpose": "Review TF24 technical-file remediation status and agree next actions across risk, software, subcontractors, usability, testing and PMS.", "meetingObjectives": [ "Review tracker movement and key priorities.", "Confirm risk and cybersecurity updates.", "Review alarm, language and software-version changes.", "Track electrical compliance testing and subcontractor documentation.", "Review usability, process maps, marketing, accelerated testing, biocomp, PMS and TF03 submission dependencies." ], "executiveSummary": "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.", "overallTopicsDiscussed": [ "Tracker status", "End of August submission and November review", "Risk and software priority", "Technical file summary", "Risk management plan updates", "Risk matrix", "USB cybersecurity risk", "Alarm coding changes", "Clinical and usability alarm review", "Language updates", "Change request", "Electrical compliance testing", "Subcontractor spreadsheet", "Usability specifications", "Task analysis", "Formative study timing", "Process maps", "Marketing materials", "Accelerated testing", "Biocomp testing", "PMS comments", "TF03 MDR findings submission" ], "discussion": [ "The tracker has moved positively, with fewer documents in the 20 to 39 percent completion band.", "The main technical-file priorities remain risk and software.", "Cybersecurity updates are needed because of USB ports on the back of the CPAP machine.", "Rebecca is updating the risk management plan and matrix, including more detail on FMEAs across software, hardware and related areas.", "Andrew has progressed alarm-related software changes across sound, flash and colour.", "The remaining alarm issue is how the mute button affects the flash sequence.", "Clinical review with Janine and Adil is needed to confirm whether the alarm changes are acceptable in the field.", "The alarm changes are expected to be handled through a change request review.", "The firmware appears to have capacity for the 12 additional languages.", "Arabic, Vietnamese and Greek may need symbol or font support before the translated GUI files can be fully loaded.", "The alarm and language updates will produce a new software version.", "The new software version should also document the retrospective update from version 1.01 to 1.02.", "David is tracing the 17 historical software changes from version 1.01 to 1.02 and identifying any test-scenario gaps.", "Retrospective test scenarios may be needed where changes cannot be supported from existing traceability.", "Electrical compliance testing will be completed in-house and is expected to finish in the second-last week of July.", "Subcontractor documentation is mostly available, with missing items to be handled through justifications or further actions.", "Formative usability study timing is expected to fall after the initial August submission but before notified body review.", "Task analysis is mostly complete and Adil is planning how to execute the study.", "Operational process maps and procedures are awaiting finalisation with Christina.", "PMS comments from David need to feed into the relevant summary or PMS documentation." ], "actions": [ { "owner": "Rebecca", "action": "Update the risk management plan and matrix, including the cybersecurity and FMEA detail." }, { "owner": "David", "action": "Review Rebecca's updated risk-management wording and confirm it is on the right lines." }, { "owner": "Andrew", "action": "Confirm the mute-button flash behaviour and progress the clinical review of the alarm changes with Janine and Adil." }, { "owner": "Andrew", "action": "Resolve symbol or font issues for Arabic, Vietnamese and Greek so the translated language files can be loaded." }, { "owner": "David", "action": "Trace the 17 software changes from version 1.01 to 1.02 and identify where retrospective test scenarios are needed." }, { "owner": "Andrew", "action": "Work through the in-house electrical compliance testing so outputs are available for David's final software and technical-file deliverables." }, { "owner": "Rebecca", "action": "Work through subcontractor documentation gaps and agree any justifications or further actions with Louise." }, { "owner": "Adil", "action": "Plan execution of the formative usability study and align the timing with the MDR submission and notified body review window." }, { "owner": "Kevin and Christina", "action": "Finalise the operational process maps and procedures once Christina returns." }, { "owner": "Ciaran", "action": "Review David's PMS comments and incorporate them into the relevant PMS or summary documentation." } ], "humanGeneratedMinutes": { "files": [ { "label": "Human generated minutes", "file": "human_generated_minutes.pdf" } ], "meetingTitle": "T733/T817 Eakin Healthcare Consultancy Retainer - Client project checkin for TF24", "meetingDate": "17 June 2026", "objective": [ "Review status of TF24" ], "minutesDiscussion": [ "SGS approved the end of August submission date, with review planned for November 2026.", "Tracker status showed slight progress improvement and the status report was updated by owner.", "Microsoft disabled SharePoint alerts, so the Eakin team should email Trinzo when files are uploaded for review.", "Key priorities are risk and software, contract manufacturing/subcontractors and usability.", "Rebecca is actioning feedback from Colm and Louise on the technical file summary document.", "Rebecca reviewed David's risk management plan feedback and requested David to check the updates.", "Rebecca is updating the risk matrix.", "Rebecca and Andrew are reviewing cybersecurity risk and mitigation options for the USB port.", "Andrew completed the alarm coding changes across sound, flash and colour.", "One alarm issue remains around mute button behaviour.", "Clinical and usability review is needed for the changed alarm sound, flash and colour.", "Andrew proved the software has memory capacity to accept 12 additional languages.", "Full translations have been received and Andrew is updating translated files, including Greek, Arabic and Vietnamese symbol updates.", "A change request has been raised and will be reviewed by the Eakin team this week.", "Andrew will complete all electrical compliance testing in-house, starting this week.", "Electrical compliance testing is expected to complete in the second-last week of July.", "David will review the electrical compliance test results to complete final deliverables.", "Lorna provided a subcontractor missing-documentation summary, and the team is reviewing gaps for justifications.", "Subcontractor work will be finalised once Christina returns from holiday and follows up with Louise.", "Both usability specifications are complete.", "Adil completed the task analysis with input from Alan and Abby and now needs to plan and execute the study.", "The formative study is likely to be ready after the August MDR submission, with August to November used for updates.", "Process maps remain ongoing, with Christina's review complete and a call planned with Kevin and Christina.", "Marketing brochures and related materials are under ongoing completeness review.", "Accelerated testing remains on track for week three of July.", "Biocomp testing will be managed by Chorley, with Rebecca reviewing Louise's feedback.", "David reviewed the PMS and added comments for Ciaran to integrate after the TF03 submission.", "TF03 MDR findings submission is due on 21 June." ], "minutesActions": [ { "owner": "David", "action": "Review Rebecca's updates to the risk management plan.", "deadline": "22 June 2026" }, { "owner": "Andrew", "action": "Complete clinical and usability review of the alarm changes.", "deadline": "26 June 2026" }, { "owner": "Rebecca and Christina", "action": "Complete the subcontractor spreadsheet and justifications.", "deadline": "26 June 2026" } ] } } }