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.
Genre:
Added Corporate Author:
Electronic Access:
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Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 547334-1001 | R856 .A2 | Searching... | Searching... |