What is the scope of contract review? What triggers a contract review? We are currently reviewing all POs regardless whether they are for existing parts or for new parts. It seems like overkill and basically contract review has become a production planning process rather than a contract review process. The focus is purely on do we have the material and capacity to meet the customers due date. By doing this this, we miss a thorough review of new part requirements because we are overloaded with existing part contract reviews that need to be quickly.
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
For medical devices, all contracts must be reviewed to be sure that all requirements from the MDR point of view are settled. Whether all contracts will be reviewed depends primarily on whether they are critical parts or parts that can be purchased/acquired anywhere. For critical parts, it is important to be sure that the supplier will inform you of any changes in their product that could affect the quality of the final medical product.
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Apr 05, 2024