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El. knyga: Design Controls for the Medical Device Industry, Third Edition 3rd edition [Taylor & Francis e-book]

  • Formatas: 248 pages, 13 Tables, black and white; 16 Illustrations, black and white
  • Išleidimo metai: 15-Aug-2019
  • Leidėjas: CRC Press Inc
  • ISBN-13: 9781351261487
Kitos knygos pagal šią temą:
  • Taylor & Francis e-book
  • Kaina: 244,66 €*
  • * this price gives unlimited concurrent access for unlimited time
  • Standartinė kaina: 349,51 €
  • Sutaupote 30%
Design Controls for the Medical Device Industry, Third Edition 3rd editionDidesnis paveikslėlis
  • Formatas: 248 pages, 13 Tables, black and white; 16 Illustrations, black and white
  • Išleidimo metai: 15-Aug-2019
  • Leidėjas: CRC Press Inc
  • ISBN-13: 9781351261487
Kitos knygos pagal šią temą:
Taylor & Francis e-booksMore info about Taylor & Francis e-books
Partnerių interneto svetainė: https://www.taylorfrancis.com/books/9781351261487
This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations.

The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study.

This third edition:











Examines new coverage of ISO 13485-2016 design control requirements





Explores proven techniques and methods for compliance





Contributes fresh templates for practical implementation





Provides updated chapters with additional details for greater understanding and compliance





Offers an easy to understand breakdown of design control requirements





Reference to MDSAP design control requirements
Preface xi
Author xiii
Chapter 1 Introduction
1(4)
Chapter 2 Device classification
5(4)
Chapter 3 Overview of design controls
9(10)
Applicability
9(1)
Design controls and the bottom line
9(2)
When might design controls be considered?
11(1)
What are the benefits of design control other than the obvious mandate?
11(1)
An idea is born
12(1)
Ask the customer
12(1)
Design controls and the customer
13(1)
Design and development phases
13(6)
The first phase: Definition--i.e., design input
14(1)
The second phase: Develop outputs--i.e., design and development
15(1)
The third phase: Design verification
16(1)
The fourth phase: Design validation
17(1)
The fifth phase: Product release
17(1)
The sixth phase: Improvement and optimization
18(1)
Chapter 4 Design and development planning
19(12)
Do we really need a plan?
19(1)
Design and development planning requirements
20(4)
Key elements of a design and development plan?
24(1)
Planning techniques
25(3)
Gantt charts
25(2)
When is a good time to use a Gantt chart?
27(1)
When might a Gantt chart not be appropriate?
27(1)
PERT charts
27(1)
What are the advantages of using PERT?
27(1)
When might PERT not be appropriate?
28(1)
Project planning--How do I get started?
28(3)
Chapter 5 Design inputs: Part 1
31(10)
The concept document
31(2)
Design input
33(2)
What are design inputs?
35(1)
Design input requirements
35(2)
Where do design inputs come from?
37(1)
How do we document our inputs?
38(3)
Chapter 6 Design inputs: Part II
41(34)
Performance characteristics--e.g., user requirements
42(5)
Indications for use
42(1)
Clinical procedure for use
43(1)
Relevant use setting/environment
44(1)
Medical specialty of the user
45(1)
Patient population--inclusion/exclusion criteria
45(1)
User interface/ergonomic considerations
46(1)
Product characteristics--i.e., product requirements
47(17)
Physical characteristics
48(1)
Chemical characteristics
49(1)
Biological characteristics
50(2)
Selection of tests
52(1)
Environmental characteristics
53(1)
Transport and storage
53(1)
Use environment
54(1)
Sterilization and sterile barrier characteristics
55(1)
Methods of sterilization
55(1)
Aseptic processing
56(1)
Reusable medical devices
56(2)
Packaging and labeling characteristics
58(2)
Equipment interface characteristics
60(3)
Safety and reliability characteristics
63(1)
Marketing requirements
64(7)
Intended marketplace
64(1)
Contractual requirements
65(1)
Claims
65(2)
Labeling requirements
67(3)
Patents, trademarks, and licensing agreements
70(1)
Clinical information
70(1)
Regulatory and quality assurance requirements
71(1)
Classification
71(1)
Device approval requirements
71(1)
Relevant regulatory or harmonized standards
71(1)
Labeling
72(1)
Contractual agreements
72(1)
Financial requirements
72(1)
Design specifications
73(1)
One more step
73(2)
Chapter 7 Design outputs
75(6)
Design output requirements
76(1)
Typical design outputs
77(1)
Device master record
78(3)
Chapter 8 Design review
81(18)
Not another meeting!
81(1)
FDA and design review
81(1)
Design review requirements
82(1)
Design team members
83(1)
Design review focus
83(1)
Design review elements
84(1)
Design review meetings
85(6)
Phase 1 Design input phase review
86(1)
Phase 2 Design and development phase review
87(1)
Phase 3 Design verification phase review
88(1)
Phase 4 Design validation phase review
89(1)
Phase 5 Design release and approval for sale (i.e., product launch)
89(1)
Phase 6 Use design review meeting
90(1)
Documenting the design review
91(1)
Meeting dynamics
91(8)
Communication skills
91(1)
Did they get it?
92(1)
Listen and validate
93(1)
Accept the bad news
94(1)
Monitor and measure
94(1)
Don't confuse motion with progress
95(1)
Meeting minutes
95(1)
Making decisions that solve problems
95(4)
Chapter 9 Design verification
99(6)
What is the purpose of design verification?
99(1)
What is design verification?
99(1)
Design verification--Definitions
99(1)
Design verification requirements
100(1)
Design verification process
101(1)
Verification activities
101(3)
A word of advice
104(1)
Chapter 10 Risk management
105(14)
Why?
105(1)
How does risk management fit into design and development?
105(2)
What is risk management?
107(1)
The risk management process
107(1)
Risk analysis
108(1)
Human factors and the risk management process
109(3)
Risk evaluation
112(1)
Risk control
113(2)
Risk review
115(1)
Post-production risk management
116(3)
Chapter 11 Design validation
119(10)
Why validate?
119(1)
What is design validation?
119(1)
Design validation requirements
120(4)
Design validation process
124(2)
Validation activities
126(1)
Design validation results
126(1)
Risk assessment of medical device materials and the finished device
127(2)
Chapter 12 Biocompatibility
129(26)
Duration of use
130(1)
Degree of invasiveness
130(2)
Biological effects/end points
132(1)
Biological testing considerations
132(2)
Regulatory aspects of biocompatibility
134(5)
Biocompatibility testing programs
139(1)
Phases of biocompatibility testing
140(2)
Screening tests
142(1)
Systemic toxicity
142(2)
Cytotoxicity and cell cultures
144(2)
Evaluation using extracts
144(1)
Evaluation by direct contact
145(1)
Evaluation by indirect contact
146(1)
USP biological tests
146(1)
Irritation tests
147(1)
Sensitization tests
148(1)
Hemocompatibility tests
148(2)
Implantation tests
150(1)
Mutagenicity tests (genotoxicity)
150(1)
Supplemental testing
151(1)
Carcinogenicity testing
152(1)
Reproductive and developmental toxicity
152(1)
Biodegradation
153(2)
Chapter 13 Design transfer
155(6)
Importance of design transfer
155(1)
Design transfer requirements
156(1)
Design transfer
157(1)
The design transfer checklist
157(2)
Design release
159(2)
Chapter 14 Design change
161(6)
Why control design changes
161(1)
Design change examples
161(2)
Design change requirements
163(1)
Design change procedure
163(1)
Evaluation of design changes
163(2)
Documenting design changes
165(2)
Chapter 15 Design history file
167(4)
Why do we need a design history file?
167(1)
What is a design history file?
167(1)
Design history file requirements
167(1)
Design history file elements
168(3)
Chapter 16 The FDA inspection technique
171(4)
Oh no! The FDA investigator is here
171(1)
General design control requirements
171(4)
Design and development planning
171(1)
Design input
172(1)
Design output
172(1)
Design review
173(1)
Design verification
173(1)
Design validation
174(1)
Design transfer
174(1)
Design changes
174(1)
Design history file
174(1)
Appendix A Design controls procedure 175(24)
Appendix B Design input document 199(4)
Appendix C Product claims sheet 203(2)
Appendix D Input/Output design traceability matrix 205(2)
Appendix E Project approval form 207(2)
Appendix F Design phase review meeting record 209(6)
Appendix G Risk analysis 215(6)
Appendix H Clinical evaluation report 221(4)
Appendix I Design transfer checklist 225(2)
Appendix J Design change form 227(2)
Appendix K Approval for sale form 229(2)
Appendix L Engineering change order form 231(10)
References 241(2)
Index 243
Marie B. Teixeira is the founder and principal consultant for QA/RA Compliance Connection, Inc. in Odessa, Florida. QARACC is a world-class consulting company providing expert management and guidance for its clients in all aspects of global quality management and regulatory affairs. Under her direction and guidance, her clients have received ISO 9001, ISO 13485, CE and MDSAP certification and obtained regulatory clearance for their medical devices internationally.

Before beginning this venture, she was Director of Quality Assurance and Regulatory Affairs at Bioderm, Inc., a start-up medical device company in the Tampa Bay Florida area where she designed, directed and implemented the policies and procedures that established this companys compliance with global regulatory requirements.

Ms. Teixeira was also Quality Systems Manager for Regulatory Affairs at Smith & Nephews Wound Management Division in Largo, Florida. In addition to directing the planning, development and implementation of Smith & Nephews ISO 13485, FDA GMP, and MDD 93/42/EEC regulatory efforts, she implemented and directed the companys internal audit program and management review system. It was her direction and guidance that allowed Smith & Nephews Wound Management Division to achieve ISO certification in less than a year, as well as their MDD certification one year later.

Ms. Teixeira began her career as a Quality Engineer for Raytheon, GTE Government Systems and Sparton Electronics. During her tenure at these companies she was responsible for establishing and implementing quality assurance programs and procedures, leading supplier and customer audits, developing and performing quality system and auditor training, initiating and managing corrective actions, and developing and implementing supplier certification programs. During her tenure at Sparton, she managed the company through its initial ISO certification and subsequent surveillance audits.

Marie Teixeira holds a BS in Industrial Engineering and Operations Research from the University of Massachusetts at Amherst. She is a member of the American Society for Quality. Ms. Teixeira is an ASQ Certified Quality Manager and Quality Engineer and an Exemplar Global Principal Auditor. Ms. Teixeira was also an active member of an international task force CEN/TC257/SC-DETG10 - whose objective was to standardize medical device nomenclature. Ms. Teixeira recently authored her third edition of the book titled "Design Controls for the Medical Device Industry". Ms. Teixeira has also published numerous quality system related CD-ROM training modules and related informational handbooks and has conducted numerous quality system training seminars.
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