Usability Engineering and Human Factors for Medical Devices
Idioma: inglés
Editorial: Independently Published, 2022
- Tapa blanda
- Nuevo
Librería: PBShop.store UK, Fairford, GLOS, Reino UnidoPBShop.store UK
Vendedor de IberLibro desde 11 de junio de 1999
Condición: Nuevo
EUR 23,03
Cantidad disponible: Más de 20 disponibles
Añadir al carritoDescripción del artículo del vendedor
New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
N° de ref. del artículo L0-9798680239209
- Título
- Usability Engineering and Human Factors for Medical Devices
- Autor
- White, Bernadette
- Editorial
- Independently Published
- Año de publicación
- 2022
- Estado
- New
- Encuadernación
- PAP
- Idioma
- inglés
- ISBN 13
- 9798680239209
- Peso del artículo
- 109 gramos
Recent changes in regulation (e.g. MDR 2017/745) have increased the focus on usability requirements for medical devices. With stronger references to risks associated with use error and foreseeable misuse now requiring manufacturers to respond to foreseeable misuse. This short book introduces Usability Engineering and Human Factors Engineering providing a grounding in the principles of UE/HFE and the deliverables expected by manufacturers.
As medical device vary in classification, complexity, cost and intended use, it is not feasible to provide a ready-made solution for device usability. However, if usability is integrated into the product development processes and risk management processes it can achieve devices that have minimal use related hazards.
If medical devices are designed and developed without applying a usability engineering or human factors engineering, their use can be non-intuitive, difficult to learn, difficult to complete tasks and difficult to use. Furthermore, as technology and medical devices offer more innovative solutions, patients can now be tasked with using medical devices or administering their treatments, therefore usability becomes more important.
While the goal of design should aim to provide medical devices that are inherently safe, as with most medical devices, residual risks remain once a product is designed, manufactured and validated clinically. Use errors or Usability errors contribute to those potential risk scenarios where medical device usability is an issue for the user. With the increasing abundance of medical devices is the observation, treatment and monitoring of patients, use errors must be assessed for medical devices and reduced to an acceptable level. In contrast to safety inherited by design, the least and often the last protective measures are warnings or contraindications provided on labelling or instructions for use.
The strength of applying usability engineering principles (aka human factors engineering) medical devices is that use errors can be identified and mitigated through design and engineering practices, early-on in the product development and product realization cycle. Medical devices designed and developed devoid of usability engineering, are less intuitive, difficult to use and require focus and attention to learn to use them effectively. In addition, usability is a growing requirement from a regulatory perspective.
A strength of this short book is its focus on the themes of usability, risk management and design control which interact together and if managed early-on in projects can benefit the user and deliver medical devices optimised for usability and human factors. At approx. 73 pages, this book does not intend to provide an expensive textbook solution to Usability, alternatively, it is a concise guide offering a 'to-the-point' reference at great value.
“Sinopsis” puede pertenecer a otra edición de este título.
PBShop.store UK
Fairford, GLOS, Reino Unido
Vendedor de IberLibro desde 11 de junio de 1999
Tarifas de envío de Reino Unido a Estados Unidos de America
| Artículo | De 10 a 20 días hábiles | De 10 a 20 días hábiles |
|---|---|---|
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