Medical Device Design: Innovation from Concept to Market 1st Edition by Peter J. Ogrodnik – Ebook PDF Instant Download/Delivery: 0123919428, 978-0123919434
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ISBN 10: 0123919428
ISBN 13: 978-0123919434
Author: Peter J. Ogrodnik
Medical Device Design: Innovation from Concept to Market 1st Edition: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices’ regulatory (FDA and EU) requirements–some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author’s years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.
- The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how
- Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand
- Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Medical Device Design: Innovation from Concept to Market 1st Edition Table of contents:
Chapter 1: Introduction
1.1 What Is Design?
1.2 The Design Life Cycle
1.3 Medical Devices Definitions
1.4 Summary
Chapter 2: Classifying Medical Devices
2.1 Why Classify?
2.2 Classification Rules
2.3 Case Study
2.4 Models
2.5 Classification and Design Process
2.6 Summary
Chapter 3: The Design Process
3.1 Design Process vs. Design Control
3.2 Design Models
3.3 Managing Design
3.4 Regulatory Cross-Reference
3.5 Summary
Chapter 4: Implementing Design Procedures
4.1 Guidelines Review
4.2 Overall Procedure
4.3 Audit/Review Procedure
4.4 Implementation
4.5 Summary
Chapter 5: Developing Product Design Specification (PDS)
5.1 Statement of Need
5.2 Product Design Specification
5.3 Extracting and Analyzing Content
Chapter 6: Generating Ideas and Concepts
6.1 Creative Space
6.2 The Engineer’s Notebook
6.3 Concept Generation and Selection
6.4 Summary
Chapter 7: Quality in Design
7.1 Optimization
7.2 Design of Experiments
7.3 House of Quality
7.4 FMEA
7.5 Six Sigma
7.6 Summary
Chapter 8: Design Realization/Detailed Design
8.1 Design Realization Process
8.2 Assembling Design Team
8.3 Design Calculations
8.4 Materials Selection
8.5 CAD
8.6 Design for Usability
Chapter 9: Evaluation (Validation and Verification)
9.1 Risk Analysis
9.2 Criteria-Based Evaluation
9.3 Clinical Trials
9.4 Literature Review
9.5 Clinical Evaluation Report
Chapter 10: Manufacturing Supply Chain
10.1 Identifying Suppliers
10.2 Packaging
10.3 Procurement
10.4 Summary
Chapter 11: Labeling and Instructions for Use (IFUs)
11.1 Standard Symbols
11.2 Labeling and Marking
11.3 IFUs and Surgical Techniques
11.4 Declarations and Translations
Chapter 12: Postmarket Surveillance
12.1 PMS Role in Design
12.2 Tools and Contacts
12.3 Vigilance
Chapter 13: Protecting Your Intellectual Property (IP)
13.1 Types of IP Protection
13.2 Partner Communication
13.3 Summary
Chapter 14: Regulatory Approval to Market
14.1 Class I Devices
14.2 Higher Classifications
14.3 FDA and EC Processes
14.4 Getting to Market
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