Validation for Medical Device and Diagnostic Manufacturers - Image 1

Price loading...

CRC Press Validation for Medical Device and Diagnostic Manufacturers

Name: Validation for Medical Device and Diagnostic Manufacturers
Brand: CRC Press

Medical Technology

Price History & Forecast

No Price Data Available

Price history will appear here once data is collected from Amazon.

Price Distribution

No price data available for histogram

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 > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Medical Technology
Domain: Amazon UK
Release Date: 11 November 1997
Listed Since: 18 December 2006

Barcode

No barcode data available

CRC Press Validation for Medical Device and Diagnostic Manufacturers

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation

Practical Design Control Implementation for Medical Devices

Pharmaceutical and Medical Device Validation by Experimental Design

Medical Device Quality Assurance and Regulatory Compliance

CRC Press - How to Sell Validatable Equipment to Pharma

Design Controls for the Medical Device Industry, Third Edition

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

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

Six Sigma for Medical Device Design

Validating Medical Packaging

Medical Device Quality Assurance and Regulatory Compliance

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook

Validated Cleaning Technologies for Pharmaceutical Manufacturing

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

Medical Device Software Verification, Validation and Compliance

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Biomaterials, Medical Devices, and Combination Products: Biocompatibility Testing and Safety Assessment

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

Handbook of Analytical Validation

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Handbook of Analytical Validation

Dietary Supplement Good Manufacturing Practices: Preparing for Compliance

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

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs