Consiliso: The Blueprint for Integrating Business Processes in Medical Device Companies

$300.00

Finally, a detailed “how-to” textbook that contains the best architecture for mature, compliant and efficient Medical Device companies. No matter the size of your company, the Consiliso textbook explains how to determine what parts of the architecture apply to your business, and how to scale Consiliso as your company grows, develops different types of devices, or enters new markets.

  • Learn how to assess the requirements (of both the business and the applicable laws and regulations)
  • Receive detailed instruction on best-practices for key aspects of running a medical device company efficiently and in compliance
  • See, through detailed process interaction maps (that you can tweak for your types of devices) how this approach works in practice

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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

Additional information

Weight 1.81 kg
Dimensions 12 × 15 × 3 cm

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