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  • Viraj D replied to the topic Design Review Meetings in the forum Introduction to Design Controls 8 years, 9 months ago

    Design review meetings consist of many things. They review updates and changes that may be necessary and make a decision on said decision. Usually in these meetings you have a representative from each department, such as Quality, Regulatory, Marketing, and R&D. These changes or update to the development of the product consists of inputs from all the departments where all changes and discussions are drafted in meeting minutes. This is used as formal documentation that details the discussion of the decision being made. Also in these meetings, Design Input Requirements are reviewed and signed off on due to changes as well. The reason for having each member from each department present at these meetings is to assess the impact against the market, the user, feasibility wise by the engineers, and if it meets FDA standards.