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  • Juan Javier replied to the topic What are Design Controls? in the forum Introduction to Design Controls 8 years, 5 months ago

    Design verification is part of the quality control system where documents, resources, specifications, equipment installation and associated operation & performance qualifications, vendor qualifications and re-qualifications, etc. Verification is part of the quality management system and ensures that the resources utilized in making a medical device function in their intended manner.

    Design validation is to simply ensure that the device operates within the purview of the design inputs.