A Beginners Road Map to the Medical Device Industry

Erscheinungsjahr 2022
ISBN: 978-1-77469-335-3
Verlag: Arcler Press
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 291 Seiten, Electronic book text, Format (B × H): 152 mm x 229 mm

It is estimated that there are over 10 000 different medical devices available on the market today. These devices have become an integral part of health care and a vital component of the various activities carried out by health-care providers to treat people with varying medical conditions all around the world. Regulatory requirements for such devices differ from country to country all around the world which in turn make it difficult for manufacturers to obtain all round market approval for their products. While market approval from regulatory authorities can easily be obtained if a manufacturer can prove the device meets national regulatory guidelines; differences in regulatory requirements between different countries means that a manufacturer's registration process becomes more complex and ultimately may require additional resources or information.

This volume aims to provide a basic roadmap to beginners into the medical device industry. It provides a simplistic overview of the vast history behind much of the regulations and medical technology governing the field today as well as the need and importance of associated medical device regulations and essential principles governing safe and effective manufacture and use of these devices.

Fachgebiete

• Rechtswissenschaften Öffentliches Recht Medizin- und Gesundheitsrecht Arzneimittelrecht und Medizinprodukterecht, Apothekenrecht, Krankenhausrecht
• Technische Wissenschaften Technik Allgemein Technik: Allgemeines

Inhaltsverzeichnis

- Chapter 1 Introduction
- Chapter 2 Effect of Global Trends on Medical Device Demands
- Chapter 3 A Brief History of Medical Device Regulations
- Chapter 4 What Is a Medical Device?
- Chapter 5 Manufacturing a Medical Device
- Chapter 6 How Do We Ensure Safety of Medical Devices?
- Chapter 7 Regulating Medical Devices
- Chapter 8 How Can a Manufacturer Ensure Compliance?
- Chapter 9 How to Classify a Medical Device?
- Chapter 10 Understanding the Summary Technical Documentation (STED)

Über Autor(innen)

Shalinee Naidoo is currently the Regulatory and Product Development Manager of a medical device manufacturer based in South Africa. She is directly involved in global regulatory compliance and the design and development of new medical devices from idea conception to market. She is also the founder of Life of Shal (www.lifeofshal.com) an online travel journal created to inspire others to explore the world and Scientist's Sanctuary (www.scientistssanctuary.com) – a science communication company that specializes in bridging the gap between scientific knowledge and creative communication for both the academic and corporate world.