Design Controls for the Medical Device Industry
by
Teixeira, Marie, author.
Title
:
Design Controls for the Medical Device Industry
Author
:
Teixeira, Marie, author.
ISBN
:
9780429221835
Edition
:
First edition.
Physical Description
:
1 online resource (254 pages)
Contents
:
chapter 1 Overview -- chapter 2 Design and Development Planning -- chapter 3 Design Input I -- chapter 4 Design Input II -- chapter 5 Design Outputs -- chapter 6 Design Review -- chapter 7 Design Verification -- chapter 8 Design Validation -- chapter 9 Process Validation -- chapter 10 Design Transfer -- chapter 11 Design Changes -- chapter 12 The Design History File -- chapter 13 Questions to Expect in an Audit.
Abstract
:
This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.Details procedures utilize.
Subject Term
:
TECHNOLOGY & ENGINEERING / Mechanical.
TECHNOLOGY & ENGINEERING / Material Science.
Quality Control -- United States..
Equipment and Supplies -- standards -- United States..
Industry -- standards -- United States..
Equipment and Supplies -- standards.
Industry -- standards.
Quality Control.
Genre
:
Electronic books.
Added Corporate Author
:
Taylor and Francis.
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 547334-1001 | R856 .A2 | | CRC E-Books |