# Meeting Minutes

## Metadata
| | |
|---|---|
| Client | Nordvik Medical |
| Reference | T815 |
| Meeting | Audit kick-off — Trondheim |
| Date | Thursday 2 July 2026, 13:30 |
| Duration | 26m 33s |
| Attendees | Jacqui Fox, Gareth Pryce, Aoife Brennan (Trinzo); Ingrid Solberg (Nordvik Medical) |

## Objectives
Agree logistics, roles, scope and preparation for the five-day on-site audit at Trondheim, and identify anything required from Nordvik in advance.

## Executive Summary
The audit runs 20 to 24 July, preceded by a preparation week commencing 13 July and followed by report writing from 27 July to 7 August. Gareth Pryce leads, with Aoife Brennan supporting; Aoife Brennan declined ownership of the standards list on the grounds that she has not worked on a Norwegian audit and would rather learn it than produce it incorrectly, and Gareth Pryce took it on as a half-day task.

Two people were discussed at length but are not part of this meeting. Petra Lindqvist is Nordvik's internal quality lead and will accompany the audit team on site all week, arriving Monday, acting neither as auditor nor auditee but to provide access and orientation. Karl Devlin sits at the notified body and is not involved in the audit at all; he matters because the resulting report is what Nordvik will use in its autumn conversation with him, which shapes how the report should be written.

The material scope issue raised is a dose calculation feature described as AI in at least one marketing brochure, which Ingrid Solberg states is a lookup table with interpolation. Gareth Pryce identified the mismatch between a marketing AI claim and a technical file containing no AI as a likely early finding and asked for the brochure in advance, while declining Ingrid Solberg's suggestion that it would be welcome in the report.

## Key Discussion Points
| Topic | Discussion | Outcome |
|---|---|---|
| Travel | Gareth Pryce flies from Dublin and Aoife Brennan from Belfast on Sunday 19 July, both connecting through Oslo and landing within about forty minutes of each other. Trinzo has booked flights; Nordvik has booked the hotel. | Shared taxi from Trondheim airport agreed |
| Accommodation | The Britannia, booked on Nordvik's account, with no payment at the desk though a card may be requested for incidentals. | Confirmed |
| Roles | Gareth Pryce leads. Aoife Brennan supports and will shadow interviews for the first two days, potentially taking one interview alone on the Thursday at Gareth Pryce's discretion. Aoife Brennan declined to own the standards list; Gareth Pryce accepted it as a half-day task. | Agreed |
| Standards scope | Expected to cover 13485, MDR, 14971, the 60601 collateral and particular standards including 60601-1-8 for alarms and 60601-2-24 for infusion pumps, and 62304 for software. | Gareth Pryce to produce the list |
| AI claim | A dose calculation feature is described as AI in marketing material. Ingrid Solberg states it is a lookup table with interpolation and has been disputing the description internally for four months. Gareth Pryce identified the inconsistency between marketing claims and the technical file as an obvious early finding and declined to write findings to order. | Brochure to be provided in advance |
| Site access | Start at 08:00 but the gate is slow, so 07:30 arrival. Passport numbers and full names required by 10 July, otherwise a visitor badge is issued each morning costing twenty minutes daily. Safety shoes provided if sizes are supplied. No phones on the clean side and no photography anywhere on site. | Details to be submitted centrally by Jacqui Fox |
| Week structure | Gareth Pryce proposed Monday for the opening meeting and documents, Tuesday and Wednesday on the floor and in interviews, Thursday deliberately unplanned for following threads, and Friday morning for writing up with the closing meeting after lunch. Ingrid Solberg raised that Friday afternoon is difficult as staff leave early in July, and asked about closing on Thursday. Gareth Pryce was reluctant, as that removes the thread-following day where most of the value sits. | Not resolved. Gareth Pryce to propose an alternative shape in writing next week |
| Preparation materials | Aoife Brennan asked for a previous report as a model for structure. | Jacqui Fox to supply a redacted example from another client |
| Practicalities | The site canteen closes at 12:30. | Noted |

## Actions
| Owner | Action | Due |
|---|---|---|
| Gareth Pryce | Complete the scope work and produce the standards list | Fri 10 July |
| Aoife Brennan | Review the standards list and come to the preparation sessions with questions | Week commencing 13 July |
| Gareth Pryce, Aoife Brennan | Send full names, passport details and safety shoe sizes to Jacqui Fox | Thu 9 July |
| Jacqui Fox | Forward site security details to Nordvik in a single submission | Fri 10 July |
| Ingrid Solberg | Send the marketing brochure containing the AI description | Before 20 July |
| Gareth Pryce | Propose a revised shape for the on-site week in writing, addressing the Friday afternoon constraint | Week commencing 6 July |
| Jacqui Fox | Provide Aoife Brennan with a redacted previous audit report as a structural example | Week commencing 13 July |

## Key Dates
| Date | Activity |
|---|---|
| Fri 10 July | Security details deadline; standards list complete |
| Week commencing 13 July | Preparation and training |
| Sun 19 July | Travel to Trondheim |
| Mon 20 – Fri 24 July | On site, five days |
| Mon 27 July – Fri 7 August | Report writing |