This book provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. This includes the following applications:
Statistical Policy
Process Validation
Design Verification
Component/Material Qualifications
Design Validation
Audits and Effectiveness Checks
Test Method Validation
Manufacturing Acceptance Sampling Plans and Inspections
Trending Data
Setting Specifications
The book is intended for a single user. While it can be loaned to someone, it should not be given to multiple individuals at the same time. The pdf includes the name and email of the owner on each page.
名称 | Statistical Procedures for the Medical Device Industry |
作者 | Wayne A. Taylor |
出版商 | Taylor Enterprises, Incorporated, 2017 |
ISBN | 0963512293, 9780963512291 |
页数 | 580页 |