Usability Testing of Medical Devices
Michael E. Wiklund P. E.
Sold by AHA-BUCH GmbH, Einbeck, Germany
AbeBooks Seller since 14 August 2006
New - Hardcover
Condition: New
Ships from Germany to U.S.A.
Quantity: 1 available
Add to basketSold by AHA-BUCH GmbH, Einbeck, Germany
AbeBooks Seller since 14 August 2006
Condition: New
Quantity: 1 available
Add to basketnach der Bestellung gedruckt Neuware - Printed after ordering - Since publication of the first edition, the FDA and other organizations and agencies have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this second edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates include guidance pertaining to new FDA and IEC requirements, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests.
Seller Inventory # 9781466595880
Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.
Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests.
Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process―and thus, safe and effective medical devices.
Michael E. Wiklund is general manager of the human factors engineering (HFE) practice at UL-Wiklund, as well as professor of the practice at Tufts University, where he teaches courses on HFE. He has more than 30 years of experience in HFE, much of which has focused on medical technology development. His work has involved optimizing the safety, effectiveness, usability, and appeal of various products. Widely published, he is a certified human factors professional and one of the primary contributors to today’s most pertinent guidelines on the HFE of medical devices: AAMI HE75 and IEC 62366.
Jonathan Kendler is design director of UL-Wiklund’s human factors engineering (HFE) team. He has worked in the HFE profession since receiving his bachelor of fine arts degree in visual design from the School of the Museum of Fine Arts, Boston. He earned his master’s degree in human factors in information design from now Bentley University. His design portfolio ranges from small, handheld medical devices to room-size diagnostic scanners. In addition, he has co-taught applied software user interface design at Tufts University, and delivered HFE workshops to medical and nonmedical clients.
Allison Y. Strochlic is research director of UL-Wiklund’s human factors engineering (HFE) team. She earned her bachelor of science degree in HFE from Tufts University, and her master’s degree in human factors in information design from Bentley University. A board-certified human factors professional, she is a member of the Human Factors and Ergonomics Society New England Chapter, User Experience Professionals Association, and Association for the Advancement of Medical Instrumentation Home Use Environment Committee. She has served as a part-time lecturer at Tufts University, and delivered multiple presentations to industry and academic audiences.
"About this title" may belong to another edition of this title.
General Terms and Conditions and Customer Information / Privacy Policy
I. General Terms and Conditions
§ 1 Basic provisions
(1) The following terms and conditions apply to all contracts that you conclude with us as a provider (AHA-BUCH GmbH) via the Internet platforms AbeBooks and/or ZVAB. Unless otherwise agreed, the inclusion of any of your own terms and conditions used by you will be objected to
(2) A consumer within the meaning of the following regulations is any natural person who concludes...
**Right of withdrawal for consumers **
(A consumer is any natural person who concludes a legal transaction for purposes that can predominantly be attributed neither to their commercial nor their independent professional activity.)
Cancellation
Withdrawal
You have the right to revoke this contract within fourteen days without giving reasons.
The revocation period is fourteen days from the day,
on which you or a third party named by you, who is not the carrier, has taken possession of the goods, provided that you have ordered one or more goods within the framework of a uniform order and these are or will be delivered uniformly;
on which you or a third party named by you, who is not the carrier, has taken possession of the last goods, provided that you have ordered several goods within the framework of a single order and these are delivered separately;
on which you or a third party named by you, who is not the carrier, has taken possession of the last partial shipment or the last piece, provided that you have ordered goods that are delivered in several partial shipments or pieces;
In order to exercise your right of withdrawal, you must inform us (AHA-BUCH GmbH, Garlebsen 48, 37574 Einbeck, telephone number: 05563 9996039, fax number: 05563 9995974, e-mail address: service@aha-buch.de) of your decision to revoke this contract by means of a clear declaration (e.B. a letter sent by post, fax or e-mail). You can use the attached model withdrawal form, but this is not mandatory.
To comply with the revocation period, it is sufficient that you send the notification of the exercise of the right of revocation before the expiry of the revocation period.
Consequences of revocation
If you withdraw from this contract, we shall reimburse you all payments that we have received from you, including delivery costs (with the exception of the additional costs resulting from the fact that you have chosen a different type of delivery than the cheapest standard delivery offered by us), immediately and at the latest within fourteen days from the day on which we received the notification of your revocation of this contract.
For this repayment, we will use the same means of payment that you used for the original transaction, unless expressly agreed otherwise with you; in no case will you be charged any fees for this repayment.
We may withhold reimbursement until we have received the goods back or until you have provided proof that you have returned the goods, whichever is the earlier.
You must return or hand over the goods to us immediately and in any case at the latest within fourteen days from the day on which you inform us of the revocation of this contract. The deadline is met if you send the goods before the expiry of the period of fourteen days.
You bear the direct costs of returning the goods.
You only have to pay for any loss of value of the goods if this loss of value is due to handling of the goods that is not necessary to check the nature, characteristics and functioning of the goods.
Reasons for exclusion or extinction
The right of revocation does not apply to contracts
The right of revocation expires prematurely in the case of contracts
Sample withdrawal form
(If you want to cancel the contract, please fill out this form and send it back.)
To AHA-BUCH GmbH, Garlebsen 48, 37574 Einbeck, fax number: 05563 9995974, e-mail address: service@aha-buch.de :
I/we () hereby revoke the contract concluded by me/us () for the purchase of the following goods ()/
the provision of the following service ()
Ordered on ()/ received on ()
Name of the consumer(s)
Address of the consumer(s)
Signature of the consumer(s) (only in case of notification on paper)
Date
(*) Delete as appropriate.
We ship your order after we received them
for articles on hand latest 24 hours,
for articles with overnight supply latest 48 hours.
In case we need to order an article from our supplier our dispatch time depends on the reception date of the articles, but the articles will be shipped on the same day.
Our goal is to send the ordered articles in the fastest, but also most efficient and secure way to our customers.
| Order quantity | 30 to 40 business days | 7 to 14 business days |
|---|---|---|
| First item | £ 55.69 | £ 64.33 |
Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.