Dr. Wayne Taylor - Taylor Enterprises, Inc.
for Engineers and Quality in the FDA Regulated Industries
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Statistical Procedures for the Medical Device Industry - Book
PDF, Hardcover starting at $295
Company Licenses are also available.
978-0-9635122-9-1, 8.5 x 11, 592 pages
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
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
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
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.
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:
Technical Briefs: While the procedures provide rationales and justification to backup the recommended approaches they also references the following technical briefs:
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 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