Applied Human Factors in Medical Device Design
Editat de Mary Beth Priviteraen Limba Engleză Paperback – 18 iun 2019
- Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU)
- Explains technology development and the application of human factors throughout the development process
- Covers FDA and MHRA regulations
- Includes case examples with each method
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Specificații
ISBN-13: 9780128161630
ISBN-10: 0128161639
Pagini: 368
Dimensiuni: 191 x 235 x 18 mm
Greutate: 0.64 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128161639
Pagini: 368
Dimensiuni: 191 x 235 x 18 mm
Greutate: 0.64 kg
Editura: ELSEVIER SCIENCE
Public țintă
Medical device industry professionals in human factors, design, engineering, marketing and regulatory. Students in human factors, experimental psychology, industrial design, design research, ergonomics, and biomedical engineering. Consultants and specialists of health technology assessment. Clinical engineers and health technology managers.Cuprins
1. Background on the application of HF in medical device design
2. Contents of a HF Toolbox
3. Contextual Inquiry Methods (TIR 51)
4. Heuristic Evaluation/Cognitive Walkthroughs
5. Task Analysis
6. Competitive Ergonomic Analysis
7. Known Use Error and Post Market Surveillance
8. Applied Ergonomics for UI/UX Product Design (HE 75)
9. Applied Ergonomics in Instructions for Use
10. Formative Usability Testing
11. User focused Risk Analysis
12. Summative Usability Testing
13. Preparing an HFE Report for agency submission
14. Special cases
2. Contents of a HF Toolbox
3. Contextual Inquiry Methods (TIR 51)
4. Heuristic Evaluation/Cognitive Walkthroughs
5. Task Analysis
6. Competitive Ergonomic Analysis
7. Known Use Error and Post Market Surveillance
8. Applied Ergonomics for UI/UX Product Design (HE 75)
9. Applied Ergonomics in Instructions for Use
10. Formative Usability Testing
11. User focused Risk Analysis
12. Summative Usability Testing
13. Preparing an HFE Report for agency submission
14. Special cases
Recenzii
"Overall, this text is a very good contribution to the literature and is recommended for those persons entering medical device design. It gives a very good overview of the need for and use of human factors in medical device design, especially as experienced in the United States. All information is logically presented and is, as is necessary, very patient-centric." --IEEE