Books, Quality Systems and Productivity Tools from Clinical Device Group

Books, Quality Systems and Productivity Tools...

Book order Policy
Prepayment required: Payment must be made in US dollars by US check, credit card, or wire transfer. European VAT tax is not applicable. Duties and import tax payable by customer. A pro forma invoice including shipping and other charges will be provided on request. Prices subject to change without notice. Books are tape bound or perfect bound. Handbooks are plastic-comb. Orders are shipped economy courier from Chicago, IL USA. Orders cannot be shipped to a post office box, please specify your street address. All purchases firm, items not returnable.

Biological Safety
Biocompatibility Testing and Management, Fourth Edition (2003)
Biological Safety Quality System Manual (1996)

Clinical Research
Adverse Event Wheel
Applied Regulations, Third Edition (2002)
Certified Copy Stamp
Clinical Trials Design, Third Edition (2000)
Clinical Research Quality System Manual (2009)
CRA Handbook—2009 Edition
CRA Handbook Electronic Edition—2009 Edition
Date Wheel
Good Monitoring Practices, Fourth Edition (2004)
Investigator's Guide to Clinical Research (2002)
Project Management for Clinical Studies, Second Edition (2003)

STRENGTHENING CDRH AND THE 510(K) PROCESS--CD AVAILABLE

FDA held a public meeting on 18 February 2010 to discuss issues and actions that can be taken to revise, improve, and strengthen the 510(k) process. If you missed it, you should obtain the audio recording, transcript, and slides from Clinical Device Group.

CD Contents:

[x] Agenda
[x] mp3 audio of the entire conference.
[x] Transcript of the entire conference.
[x] Photographs and identification of speakers.
[x] Slides and handouts.

Adverse Event Wheel

The Adverse Event Wheel is a convenient 'dictionary' of adverse event definitions for medical device studies. The definitions are taken from 21 CFR Part 812, ISO/DIS 14155 Clinical Investigations for Human Subjects--Good Clinical Trials (2008), and ISO 14155 (2003); and is suitable for both investigational sites and clinical trial sponsors.

When an event occurs, you spin the wheel until it lands on the set of characteristics that fit the event (subject or caregiver, device-related or not, serious or not, unanticipated or not, unreasonable risk or not). The universal definitions are given on the back of the wheel, along with instructions to report as described in the protocol.

This pocket-sized (4.25"), laminated wheel is a useful way to quickly categorize adverse events. $15.00 US. View demo.