Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation - Image 1

£122.13

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

Name: Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation
Brand: Design Controls, Risk Management and Process Validation for Medical Device Professionals
Price: 122.13 GBP
Availability: InStock

Law

Price data updated today

View at Amazon

We'll watch every seller, every day. One email when your price arrives.

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

£122 today · previous high £122 · all-time low £101

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↓ Price chart
when this has been cheap or pricey

↓ Forecast
where the price is heading next

↓ Statistics
all-time high & low, recent range

↑ Price alert
name your number, we'll email you

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 91 days • 91 data points

Historical

Generating forecast...

Price Distribution

Price distribution over 91 days • 6 price levels

Days at Price

Current Price

Price Analysis

Most common price: £107 (24 days, 26.4%)

Price range: £101 - £122

Price levels: 6 different prices over 91 days

Description

This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. As an added bonus, web access to downloadable and editable design control documents are included with this purchase. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 30-50 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Key Features

Interpretation of Design Control Regulation (21 CFR 820.30)

Practical Implementation Techniques and Best Practices

Case Studies

Downloadable and Editable Design and Development Document Templates

Product Specifications

Brand: Design Controls, Risk Management and Process Validation for Medical Device Professionals
Format: paperback
ASIN: 0692835415
Category: Books > Subjects > Business, Finance & Law > Law
Domain: Amazon UK
Release Date: 11 February 2017
Listed Since: 11 February 2017

Barcode

No barcode data available

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

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

Price History & Forecast

Price Distribution

Price Analysis

Description

Key Features

Product Specifications

Barcode

Similar Products You Might Like

ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

Design Controls for the Medical Device Industry, Third Edition

Proactive Supplier Management in the Medical Device Industry

Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Practical Design Control Implementation for Medical Devices

Practical Design Control Implementation for Medical Devices

Design Engineering and Science

Quality in the Era of Industry 4.0: Integrating Tradition and Innovation in the Age of Data and AI

Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

Product Design Review: A Methodology for Error-Free Product Development

Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745

Integrated Product and Process Design and Development: The Product Realization Process, Second Edition

CRC Press - Design of Devices and Systems: Revised and Expanded

Integrated Product and Process Design and Development: The Product Realization Process, Second Edition (Environmental & Energy Engineering)

Preventing Medical Device Recalls

Product Development: A Structured Approach to Consumer Product Development, Design, and Manufacture

3D Printing for Product Designers: Innovative Strategies Using Additive Manufacturing

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition

Design for Excellence in Electronics Manufacturing (Quality and Reliability Engineering Series)

Safety Risk Management for Medical Devices

Validation for Medical Device and Diagnostic Manufacturers

Medical Device Guidelines and Regulations Handbook

Advances in Manufacturing, Production Management and Process Control: Proceedings of the AHFE 2019 International Conference on Human Aspects of ... in ... July 24-28, 2019, Washington D.C., USA