Design controls for the medical device industry

196 Pages·2013·20.117 MB·English

by  Marie B Teixeira

Biomedical Engineering
t
e
ix
e
Design Controls ira
For the D
e
s
ig
MEDICAL DEVICE
n

C
o
InDustry n
t
r
o
sECOnD EDItIOn
l
s

F
the second edition of a bestseller, Design Controls for the Medical Device o
Industry provides a comprehensive review of the latest design control r

requirements, as well as proven tools and techniques to ensure your t
h
company’s design control program evolves in accordance with current
e
industry practice. the text assists in the development of an effective design
M
control program that not only satisfies the us FDA Quality system regulation
E
(Qsr) and IsO 9001 and 13485 standards, but also meets today’s third-party D
auditor/investigator expectations and saves you valuable time and money. IC
A
the author’s continual participation in FDA Qsr inspections and notified Body L

D
IsO audits is reflected in updates to all chapters and appendices of the book,
E
now bursting at the seams with
V
I
C
• new coverage of IsO 9001 and 13485 design control requirements E

I
n
• More real-world examples from the medical device industry
D
u
• Additional detail for greater understanding and clarity
s
t
• Fresh templates for practical implementation r
y

• Extensive references for further study s
E
C
the book addresses design control elements such as design planning, input, O
n
output, review, verification, validation, change, transfer, and history, as well D

as risk management inclusive of human factors and usability, biocompatibility, E
D
the FDA Quality system Inspection technique (QsIt) for design controls, and It
I
medical device regulations and classes in the us, Canada, and Europe. O
n
Marie B. teixeira
K14470
ISBN: 978-1-4665-0354-0
90000
9 781466 503540
K14470_COVER_final.indd 1 10/10/13 3:01 PM
Design Controls
For the
MEDICAL DEVICE
InDustry
seConD eDition

Design Controls
For the
MEDICAL DEVICE
InDustry
seConD eDition
Marie B. teixeira
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2014 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Version Date: 20131018
International Standard Book Number-13: 978-1-4665-0355-7 (eBook - PDF)
This book contains information obtained from authentic and highly regarded sources. Reasonable efforts
have been made to publish reliable data and information, but the author and publisher cannot assume
responsibility for the validity of all materials or the consequences of their use. The authors and publishers
have attempted to trace the copyright holders of all material reproduced in this publication and apologize to
copyright holders if permission to publish in this form has not been obtained. If any copyright material has
not been acknowledged please write and let us know so we may rectify in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmit-
ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented,
including photocopying, microfilming, and recording, or in any information storage or retrieval system,
without written permission from the publishers.
For permission to photocopy or use material electronically from this work, please access www.copyright.
com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood
Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and
registration for a variety of users. For organizations that have been granted a photocopy license by the CCC,
a separate system of payment has been arranged.
Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used
only for identification and explanation without intent to infringe.
Visit the Taylor & Francis Web site at
http://www.taylorandfrancis.com
and the CRC Press Web site at
http://www.crcpress.com
Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Overview 1
2 Device classification . . . . . . . . . . . . . . . . . . . . . . . . . 5
3 Overview of design controls . . . . . . . . . . . . . . . . . . . . 9
Applicability 9
Design controls and the bottom line 9
An idea is born 12
Ask the customers 12
Design controls and the customer 13
4 Design and development planning . . . . . . . . . . . . . . 17
Do we really need a plan? 17
Design and development planning requirements 19
So what makes up the plan? 21
Planning techniques 22
Project planning: How do I get started? 26
5 Design inputs—Part I . . . . . . . . . . . . . . . . . . . . . . . 29
What are design inputs? 29
The foundation: Design input 30
Design input requirements 30
The concept document 31
Product performance specification 33
v
Design controls for the medical device industry
6 Design inputs—Part II . . . . . . . . . . . . . . . . . . . . . . 37
From feasibility to development 37
Performance characteristics 37
Product characteristics 43
Marketing requirements 58
Regulatory and contractual requirements 63
Design input: One final word 64
7 Design outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
From inputs to outputs 65
Design output requirements 66
Typical design outputs 67
Device master record 67
8 Design review . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Not another meeting! 69
FDA and design review 69
Meeting dynamics 75
9 Design verification . . . . . . . . . . . . . . . . . . . . . . . . . 83
What is the purpose of design verification? 83
What is design verification? 83
Design verification requirements 83
Verification activities 84
10 Risk management . . . . . . . . . . . . . . . . . . . . . . . . . 87
Why? 87
How does risk management fit into design and
development? 87
What is a risk analysis, and what is risk
management? 88
Risk management process 89
Human factors and the risk management process 95
Risk management plan 97
11 Design validation . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Why validate? 99
What is design validation? 99
vi
Contents
Design validation requirements 100
Typical validation activities 102
Risk assessment of medical device materials
and the finished device 103
12 Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Regulatory aspects of biocompatibility 106
Biocompatibility testing programs 108
Phases of biocompatibility testing 109
13 Design transfer . . . . . . . . . . . . . . . . . . . . . . . . . . 123
What is design transfer? 123
Check your attitude at the door 123
FDA and design transfer 124
Design transfer requirements 125
14 Design change . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Design change control 127
Design change requirements 127
Engineering change order or change request
form 129
15 Design history file . . . . . . . . . . . . . . . . . . . . . . . . 131
Why do we need a design history file? 131
What is a design history file? 131
Design history file requirements 131
16 The FDA inspection technique . . . . . . . . . . . . . . . . 135
Oh no! The FDA investigator is here 135
Appendix A—QARA Compliance Connection, Inc.: Design
control procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Appendix B—QARA Compliance Connection, Inc.: Product
performance specification . . . . . . . . . . . . . . . . . . . . . . . 153
Appendix C—QARA Compliance Connection, Inc.: CE product
claims sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
vii
Design controls for the medical device industry
Appendix D—QARA Compliance Connection, Inc.: Design
inputs and associated outputs matrix . . . . . . . . . . . . . . . . 161
Appendix E—QARA Compliance Connection, Inc.: Project
approval form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Appendix F—Design review meeting record . . . . . . . . . . . 165
Appendix G—QARA Compliance Connection, Inc.: Risk
management plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Appendix H—QARA Compliance Connection, Inc.: Clinical
evaluation report form . . . . . . . . . . . . . . . . . . . . . . . . . 173
Appendix I—QARA Compliance Connection, Inc.: Design
transfer checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Appendix J—QARA Compliance Connection, Inc.:
Design change form . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Appendix K—QARA Compliance Connection, Inc.:
Approval for sale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
viii
Preface
Since the design control requirements were formally mandated by the Food
and Drug Administration’s (FDA’s) Quality System Regulation (QSR) in June
1997, and revisions were made to the International Standard ISO 13485 in 2003,
expectations for compliance with design control requirements have evolved.
Furthermore, as Regulatory Authorities and Notified Bodies have become more
familiar with the intent of the design control requirements and these persons have
assessed industry’s various methods and techniques for implementing the design
control requirements, what may have passed as acceptable a number of years ago
is often deemed unacceptable or inadequate today. As such, a company’s design
control program should be dynamic in nature and continue to evolve in accor-
dance with current expectations and industry practice.
Over the past 10 years since the book was first published, I have gained additional
practical experience in understanding the expectations for compliance of various
Regulatory Authorities and Notified Bodies by participating in numerous FDA
QSR inspections and Notified Body ISO audits. My experience with various types
of companies, both large and small, and varying in functionality and exposure to
a broader range of products and systems, has given me the insight and experience
needed to develop practical systems to meet company and external regulatory
requirements. My prime goal in writing the second edition is to keep the book up
to date with the methods used to meet design control requirements and to comply
with third- party expectations for compliance.
In this second edition, I expanded the scope of the book to include ISO 9001 and
ISO 13485 requirements for design control. The book has also undergone a major
revision in an effort to add more detail for understanding and clarity and to pro-
vide more practical examples for implementation of the concepts. In addition, the
majority of the appendices have been revised or replaced with more current and
applicable templates.
In a book such as this, which covers the design control requirements applica-
ble to a broad range of products and companies, it is often difficult, and likely
ix