Month: August 2018

STAT-18: Statistical Techniques for Normality Testing and Transformations

This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose To provide guidance on normality testing to ensure the assumption of normality is adequately met when using variables sampling plans and related procedures. Related procedures include normal tolerance intervals, variables confidence limits for the …

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STAT-16: Statistical Techniques for Equivalence Testing

This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose This procedure provides statistical techniques for demonstrating equivalence of a new product or process to an existing product or process. This is an alternate approach to demonstrating the product or process meets established requirements …

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STAT-12: Verification/Validation Sampling Plans for Proportion Nonconforming

This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose This procedure provides tables and instructions for selecting sampling plans for FDA process validation and design verification to ensure they are based on a valid statistical rationale.  These determine the samples size and acceptance …

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STAT-04: Statistical Techniques for Design Verification

This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose Design verification studies are confirmatory studies to ensure the product design performs as intended.  They make pass/fail decisions as to whether the product’s design outputs (specifications, drawings) ensure each design input requirement (requirements …

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