# Meeting Minutes

## Metadata
| | |
|---|---|
| Client | Meridian Ortho |
| Reference | T802 |
| Meeting | Tech File review — weekly |
| Date | Wednesday 8 July 2026, 09:00 |
| Duration | 14m 09s |
| Attendees | Jacqui Fox, Rebecca Gill, David Didsbury (Trinzo); Dermot Nally, Sanjay Iyer (Meridian Ortho) |
| Apologies | Ffion Hargreaves (Meridian Ortho) — notes submitted in advance and read into the meeting; returns Thursday 9 July |

## Objectives
Review progress against the tracker, close out the risk management plan comments raised on 1 July, and confirm dates for software classification, UDI remediation and supplier agreements.

## Executive Summary
Two documents moved on the tracker, down from eight last week, which Jacqui Fox attributed to the labelling batch having cleared rather than to any loss of momentum. The severity band rewording is agreed within the team but cannot be signed off without Ffion Hargreaves, as it is a quality document; Dermot Nally explicitly declined to accept it on the grounds that he could not defend it in an audit. The probability band question remains unresolved and was taken out of this meeting into a dedicated session on Tuesday 14 July, after it emerged that the implant and the navigation app may need different definitions of an event.

The UDI investigation produced a more serious finding than the original issue. The duplicate basic UDI-DI did not originate with the distributor but with Meridian, where a record created in the test environment was promoted to production in approximately 2024. Only the 22 references in scope for this file have been checked, so the extent is unknown. Jacqui Fox asked for this to be written up proactively rather than left for the notified body to find. Clinical evaluation resourcing has been resolved: Louise is confirmed from 14 July with a complete draft expected 25 August.

## Key Discussion Points
| Topic | Discussion | Outcome |
|---|---|---|
| Tracker status | 33 documents in the not-started column last week, 31 this week. Two per week is the run rate that has held since May; last week's eight was the labelling batch clearing at once. | Assessed as normal, not a slowdown |
| Severity bands | David Didsbury's suggested wording ties catastrophic to death or permanent loss of function and critical to intervention required. Rebecca Gill considers the bands now distinguishable. As a Meridian quality document it needs Meridian sign-off. Dermot Nally declined to sign, stating it is not his area and he could not defend it in an audit. | Sign-off to be sought from Ffion Hargreaves on her return |
| Probability bands | Unresolved. David Didsbury has posed the question but deliberately not answered it, as the definition of an event is a clinical and engineering decision. Dermot Nally proposed per procedure; David Didsbury noted the implant is single-procedure but the navigation app is used across many, so two definitions may be required. | Not resolved. Separate 30-minute session arranged for Tuesday 14 July with David Didsbury, Dermot Nally and Rebecca Gill |
| Risk matrix | Shell built and in the folder, with pre-control and post-control justification columns at K and U for consistency with the client's other documents. | Complete |
| Software classification | Drafting has started and is not late against the 15 July commitment. Dermot Nally flagged that Marcus is away the week of the 20th and then moves onto the North American submission, which would push review to September. | Brought forward — draft to Marcus on 9 July rather than risk the September slip |
| UDI duplicate | Root cause is internal, not the distributor: a record created in the test environment was promoted with a production batch in approximately 2024. Only the 22 in-scope references have been checked, so other affected records may exist. | To be written up proactively as a short note |
| Clinical evaluation | Louise confirmed, starting 14 July. Draft and search documentation already sent to her. Six weeks quoted for a complete draft, giving 25 August. Assessed as tight but acceptable, and no later than Meridian's own evaluator would have delivered. | Resolved |
| Supplier agreements | Seven received. Five reviewed: four are satisfactory, one — the packaging supplier — is a signed purchase order with no responsibilities, no change notification clause and no obligation to notify process changes. Two coating agreements remain with legal. | Replacement quality agreement to be drafted; Meridian owner for the supplier conversation still to be identified |
| Test laboratory | Mechanical retest is unbooked and September slots go quickly. Booking sits with Meridian but feeds the technical file. | Dermot Nally to book this week |

## Actions
| Owner | Action | Due |
|---|---|---|
| Jacqui Fox | Put the revised severity band wording to Ffion Hargreaves for sign-off | Thu 9 July |
| Jacqui Fox | Set up the 30-minute probability definition session with David Didsbury, Dermot Nally and Rebecca Gill | Tue 14 July |
| Dermot Nally | Complete the software classification justification and send to Marcus for review | Thu 9 July |
| Sanjay Iyer | Write a half-page note on the duplicate UDI record covering what happened, the scope of the check performed and the recommendation | Fri 10 July |
| Rebecca Gill | Draft a replacement quality agreement for the packaging supplier using the standard template | Open |
| Jacqui Fox | Establish with Ffion Hargreaves who owns the packaging supplier relationship conversation | Thu 9 July |
| Dermot Nally | Book the mechanical retest slot at the test laboratory | This week |

## Carried Forward
| Item | Raised | Status |
|---|---|---|
| Severity band wording | 1 July | Reworded, awaiting Meridian sign-off |
| Probability event definition | 1 July | Unresolved — moved to dedicated session 14 July |
| Software classification justification | 1 July | In progress, accelerated to 9 July |
| Duplicate UDI-DI investigation | 1 July | Root cause found; potential wider scope now open |
| Coating supplier agreements | 1 July | Still with Meridian legal |

## Closed Since Last Meeting
- Risk management plan comments issued (David Didsbury, 3 July)
- Risk matrix structure built (Rebecca Gill)
- Three replacement DIs created and submitted, showing as pending validation (Sanjay Iyer)
- Clinical evaluator engaged (Louise, starting 14 July)