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Chris Vasquez replied to the topic PM: Quality Assurance Process in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
From my experience the quality assurance team performs tests on everything that comes in for product to ensure that the material meets it’s specifications. They also test materials from vendors, and ensure that the vendor material meet our specifications. From my experience the Quality assurance team’s approval on the DHR is needed before releasing the material into production. In addition, they address concerns to the quality team if the material is not compliant with our standards. In a project aspect, once the material is passed in QA it can proceed to execution and analyze the inputs/outputs.
Chris