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Dr. Wayne A. Taylor
Ann Taylor
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Statistical Procedures for the Medical Device Industry - Book

   Statistical Procedures for the Medical Device Industry - electronic version   $295 PDF (cannot be printed)    

   Statistical Procedures for the Medical Device Industry    $325 PDF & Hardcover book    

   ISBN 978-0-9635122-9-1
   8.5 x 11, 592 pages

   By: Dr. Wayne A. Taylor

Book Objective

Provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. These regulatory requirements can be found in:

Code of Federal Regulation 21CFR, Part 820 Quality System Regulations

ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes

List of Procedures

Policy and General: STAT-01 is the general policy procedure and STAT-02 provides definitions used by the procedures.

STAT-01     Statistical Policy
STAT-02     Glossary of Statistical Terms

Areas of Application: STAT-03 to STAT-11 describe the statistical requirements for each area of application. They may also provide statistical techniques that are specific to that area of application or reference a supporting statistical technique procedure.

STAT-03     Statistical Techniques for Process Validation
STAT-04     Statistical Techniques for Design Verification
STAT-05     Statistical Techniques for Component/Material Qualifications
STAT-06     Statistical Techniques for Design Validation
STAT-07     Statistical Techniques for Audits and Effectiveness Checks
STAT-08     Statistical Techniques for Test Method Validation
STAT-09     Manufacturing Acceptance Sampling Plans and Inspections
STAT-10     Statistical Techniques for Tending Data
STAT-11     Statistical Techniques for Setting Specifications

Supporting Statistical Techniques: STAT-12 to STAT-19 describe specific statistical techniques. They do not specify any additional requirements beyond those in the policy and application procedures.

STAT-12     Verification/Validation Sampling Plans for Proportion Nonconforming
STAT-13     Verification/Validation Sampling Plans for Rate of Nonconformities
STAT-14     Verification/Validation Sampling Plans for Average
STAT-15     Verification/Validation Sampling Plans for Standard Deviation and RSD
STAT-16     Statistical Techniques for Equivalence Testing
STAT-17     Statistical Techniques for Reliability Life Testing
STAT-18     Statistical Techniques for Normality Testing and Transformations
STAT-19     Rounding of Data

Intended Audience

This book is designed for engineers and scientists in the medical device industry.  However, it is also useful for any engineer or scientists involved in product design, process development or manufacturing.

Statistical Methods

This book includes step-by-step instruction for executing 43 statistical procedures including confidence intervals, equivalency studies, regression, ANOVA, designed experiments, capability studies, gauge R&R studies, normality testing, sampling plans, control charts, change-point analysis, tolerance analysis and robust design (complete list).

Aids and References:

Tables: The procedures include extensive tables of sampling plans for both validation and manufacturing.

Spreadsheets: Three spreadsheets are included in the price of the book:

STAT-10 - Control Charts

STAT-12 to 16 - Confidence Intervals and Equivalence Tests

STAT-18 - Skewness-Kurtosis Normality Tests

Technical Briefs: While the procedures provide rationales and justification to backup the recommended approaches they also references the following technical briefs:   

Normalized Individuals (IN) Control Chart

Adjusted Control Limits for U Charts

Adjusted Control Limits for P Charts

Books:  Further details about the statistical techniques covered by the procedures are available in the following books:

Guide to Validation Sampling Plans - STAT-03 to 07, STAT-12 to 17

Guide to Acceptance Sampling - STAT-09

Guide to Normality Testing and Transformations - STAT-18

Guide to Trending Data - STAT-10

Robust Tolerance Analysis - STAT-11

Optimization & Variation Reduction in Quality - STAT-10 and STAT-11

Courses: Training on all the procedures is available.

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Last modified: September 08, 2017