Validation for Medical Device and Diagnostic Manufacturers - Image 1

£225.94

This is the most expensive it has ever been. Walk away.

£226 today · previous high £226 · all-time low £223

CRC Press Validation for Medical Device and Diagnostic Manufacturers

Name: Validation for Medical Device and Diagnostic Manufacturers
Brand: CRC Press
Price: 225.94 GBP
Availability: InStock

Biological Sciences

Price Distribution

Price distribution over 26 days • 2 price levels

Days at Price

Current Price

Price Analysis

Most common price: £223 (25 days, 96.2%)

Price range: £223 - £226

Price levels: 2 different prices over 26 days

Description

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1574910639
Category: Books > Subjects > Science, Nature & Maths > Biological Sciences
Domain: Amazon UK
Release Date: 11 November 1997
Listed Since: 18 December 2006

Barcode

No barcode data available

This is the most expensive it has ever been. Walk away.

CRC Press Validation for Medical Device and Diagnostic Manufacturers

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Artech House Medical Device Software Verification and Validation

Pharmaceutical and Medical Device Validation by Experimental Design

Safety Evaluation in Medical Devices - CRC Press Guide

Medical Device Quality Assurance and Regulatory Compliance

CRC Press Computer Systems Validation Guide for Pharma

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Medical Device Quality Assurance and Regulatory Compliance

Validation of Computerized Analytical Systems - CRC Press

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

How to Sell Validatable Equipment to Pharmaceutical Manufacturers

Technology and Medical Sciences

Validation Compliance Annual: 1995

Medical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness

Medical Devices: Regulations, Standards and Practices (Woodhead Publishing Series in Biomaterials)

Software Verification and Validation for Practitioners and Managers

Handbook of Medical Device Design (Routledge Revivals)

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Independent Verification and Validation Software Engineering Book

Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences)

Clinical Evaluation of Medical Devices: Principles and Case Studies

This is the most expensive it has ever been. Walk away.

CRC Press Validation for Medical Device and Diagnostic Manufacturers

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Artech House Medical Device Software Verification and Validation

Pharmaceutical and Medical Device Validation by Experimental Design

Safety Evaluation in Medical Devices - CRC Press Guide

Medical Device Quality Assurance and Regulatory Compliance

CRC Press Computer Systems Validation Guide for Pharma

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Medical Device Quality Assurance and Regulatory Compliance

Validation of Computerized Analytical Systems - CRC Press

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

How to Sell Validatable Equipment to Pharmaceutical Manufacturers

Technology and Medical Sciences

Validation Compliance Annual: 1995

Medical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness

Medical Devices: Regulations, Standards and Practices (Woodhead Publishing Series in Biomaterials)

Software Verification and Validation for Practitioners and Managers

Handbook of Medical Device Design (Routledge Revivals)

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Independent Verification and Validation Software Engineering Book

Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences)

Clinical Evaluation of Medical Devices: Principles and Case Studies