Truth is: I have never worked in industry to participate in Design Review Meetings. However, if such a meetings is to produce any useful results for the company it must be aimed at ensuring that a project is moving forward and if it has anything to do with a project then it must be designed to cover a phase of the project.

This is a project. It is therefore be on budget. This meeting is designed to ensure money is not wasted doing things that have not been budgeted for.

Projects are very defined action plans to end up with the production of a medical device that is placed in the market. So the Design Review Meeting must follow the nature of the project.

1st and foremost a project manager must have developed a Gantt chart with an associated Pert chart. Gantt charts are sectioned to mark the units of the project; the end of each unit is the milestone of the project. The purpose of the meeting is to see how well the team is doing in getting the project moving forward. The team should comprise the engineers, the regulatory personnel, and the quality experts.

An agenda should have been drawn out by the project manager.

During the meeting, each section of the team should be given a chance, following the agenda, to present its aspect of the project in accordance with what has occurred during the course of carrying out chores involved in the phase of the project. After each presentation, the team should fully discuss the presentation in accordance with the needs of the project. After each presentation any suggestions, or ideas relevant to the project are discussed, guided by the project manager; failures and successes by each aspect of the project team should be reviewed carefully, plans to fix failures and improve on the successes are also addressed.

Only what is relevant to the project is allowed to be discussed here.

The Manager should lay down the plan to ensure success on the next phase of the project. All this while, the FDA standards are ensured during the presentations by the individual representing the FDA interests.

On the last Design Review Meeting paying all to be payed is moved out of the way and the product brought to a successful completion.