August 2018

STAT-18: Statistical Techniques for Normality Testing and Transformations

30 Comments / Normality Testing and Transformations / By Wayne Taylor

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

8 Comments / Statistical Policy and General / By Wayne Taylor

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

49 Comments / Audits and Effectiveness Checks, Design Validation (Clinical and User Testing), Design Verification (Product Testing), Process Validation (Process and Supplier Testing), Validation Sampling Plans / By Wayne Taylor

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

43 Comments / Design Verification (Product Testing) / By Wayne Taylor

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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STAT-18: Statistical Techniques for Normality Testing and Transformations

STAT-16: Statistical Techniques for Equivalence Testing

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

STAT-04: Statistical Techniques for Design Verification

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