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Medical device manufacturers struggle to achieve the efficiency of high volume commercial manufacturers while adhering to stringent regulatory quality and traceability requirements. This presentation will demonstrate how to implement an automated manufacturing process control system that meets and surpasses ISO 13485 and FDA requirements in a lean manufacturing environment. With limited modifications to commercially available software, manufacturers can recognize benefits including: expedited new product introduction (NPI); reduced production costs; improved operating efficiency; and increased quality & traceability.
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