Description
This is it–your “Medical Device Company in a Box.” In addition to the chapters listed below, the textbook Consiliso: The Blueprint for Integrating Business Processes in Medical Device Companies contains detailed process interaction maps, guidance for constructing your policy documents (such as your Quality Manual), and implementation plans.
TABLE OF CONTENTS
SECTION I – Background
1 Historical Development of Business Systems and Processes
2 Non-Compliance: Problems and Plans
3 Company Hierarchies and Information Structures
4 Company Maturity Levels
5 Risk Management Methodologies
SECTION II – Business Systems
6 Business Systems Types
7 Sites/Business Unit Lifecycle
8 Product Quality System (ISO 13485)
9 Product Regulatory System
10 Clinical Investigation System
11 Human Resource System – Personnel Business lifecycle
12 Financial System (SOX/GAAP)
13 Health and Safety System (ISO 18001)
14 Environmental System (ISO 14001)
15 Product Lifecycle System
16 Information Business management System
17 Investor/Media/Public Relations
18 Legal System
19 Customer Relationships
20 Supplier Relationships
21 Corporate Risk Management
SECTION III – Business Processes
22 Processes/Information Flow/Tools
23 Types of Business Processes
24 Management Processes
25 Auditing
26 Documentation
27 Standards/Requirements Management
28 Competency Awareness and Training
29 Records Management
30 Issue Management Process
31 Product Line/ID and Trace
32 Product Hierarchy
33 Equipment Lifecycle
34 Product Software Development Lifecycle
35 Capital System Lifecycle
36 Design Control/Risk Management Lifecycle
37 Post Market Quality/Risk Management Lifecycle
38 Regulatory Submission Structure/STED
39 Product Release Management
40 Product Transfer
41 Product Labeling, Marketing Material, Image and Artwork Management
SECTION IV- Tools and How-to
42 Tools
43 Data/Numbering Standard
44 Tips, Tricks and Requirements
45 KPIs/Objectives/Reporting
Appendices
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