Statistical Procedures For The Medical Device Industry Dr Wayne A Taylor by Dr. Wayne A. Taylor 9780963512291, 0963512293 instant download after payment.

Code of Federal Regulation 21 CFR, Part 820—Quality System Regulations mentions the word“procedure” 82 times. Every section of Part 820 with statistical requirements includes the word“procedure” or refers to a section that includes the word “procedure.” ISO 13485:2016 Section 8.4 requires procedures for the analysis of data. This is my attempt to provide a set of procedures that meets these regulations. There are 19 procedures covering statistical policy, process validation, design verification, component or material qualifications, design validation, audits, effectiveness checks, test method validation, manufacturing acceptance sampling plans, trending data and setting specifications. Step-by-step instructions are provided for using 43 statistical methods, including confidence intervals, equivalence tests, capability studies, design of experiments, regression, analysis of variance, normality testing, tolerance analysis, robust design methods, gauge R&R studies, Pareto charts, control charts, change-point analysis, reliability testing and acceptance sampling plans. Sampling plans include attribute and variables sampling plans for proportion nonconforming and sampling plans for rates, averages, standard deviations and relative standard deviations.