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Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration -

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry.

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Failure Mode & Effects Analysis (FMEA) - The Tool of Choice to Improve Product and Process Reliabili

Failure Mode and Effects Analysis is a tried an proven technique to improve the quality, reliability and safety of products and processes in a proactive manner

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