Process design for Class 3 medical devices

2012-02-23View Original

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I would appreciate some guidance: How should the process layout for factories producing Class 3 medical devices be planned? It would be helpful to have sample layout diagrams for reference. The standardization and production processes are understandable, but I’m not sure how to determine the relative positions and sizes of the various functions. Are there books like the “Medical Device GMP Guidelines”? Guidelines for GMP in the area of formulations include example diagrams, which make things easier to understand. Thank you all for your advice

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Process design for Class 3 medical devices

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