{"id":5405,"date":"2021-04-22T14:23:48","date_gmt":"2021-04-22T12:23:48","guid":{"rendered":"https:\/\/mec-abc.de\/business-services\/technical-documentation\/usability-engineering\/"},"modified":"2021-11-12T08:13:07","modified_gmt":"2021-11-12T07:13:07","slug":"usability-engineering","status":"publish","type":"page","link":"https:\/\/mec-abc.de\/en\/business-services\/technical-documentation\/usability-engineering\/","title":{"rendered":"Usability Engineering"},"content":{"rendered":"\t\t
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Usability Engineering<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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REGULATORY AFFAIRS under MDR<\/p>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Usability Engineering<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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The usability engineering process is an important foundation in the development of safe and usable medical devices. The European Medical Device Regulation (MDR) 2017\/745 includes numerous requirements with regard to the usability and ergonomics of medical devices to reduce risks due to application errors by patients, users and third parties. Medical devices developed without applying a usability-oriented development process can lead to user-product interfaces (user interfaces) that are difficult to apply and thus to user errors. Through the systematic use of usability engineering, potential hazards that may arise during the use of the medical device can be uncovered and the likelihood of application errors can be reduced or prevented through appropriate adaptation of the user-product interface (user interfaces).<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Usability Engineering<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Our Services Usability Engineering<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tCreation of an IEC 62366-1 compliant usability engineering file<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tUpdate and revise your usability engineering file throughout the life cycle of the medical device with information from the production phase and post-market surveillance (PMS)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tConsulting for the creation of an IEC 62366-1 compliant usability file (Usability Engineering File)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tTrainings\/workshops on usability engineering<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    suitability for use<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    Manufacturers of medical devices are therefore obliged to take usability into account duringthe development process and to develop and produce their products in such a way that their use does not endanger the health and safety of patients, users or, where applicable, third parties. The information provided by the manufacturer must also be easy to understand and apply.<\/p>\n

    Some of the requirements of the MDR<\/b> for manufacturers in terms of usability and ergonomics of medical devices are, for example:<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tAnnex I, Chapter 1 (5): Reduction of risks due to ergonomic characteristics of the product and the environment, taking into account the technical knowledge, experience, education and training, the environment of use if applicable, and the health and physical condition of the intended users<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tAnnex I, Chapter 2 (14.6): Design and manufacture of measuring, control or indicating equipment to comply with ergonomic principles in view of the intended purpose, the intended users and the environmental conditions in which the products are to be used <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tAnnex I, Chapter 2 (22.2): Devices for use by lay persons shall be designed and manufactured in such a way that they can be used safely and without error and that the risk of incorrect handling of the device or, where appropriate, incorrect interpretation of the results by the intended user is minimized <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tAnnex I, Chapter 2 (22.3): Devices for use by lay persons should be provided with a procedure by which the lay person can check whether the device works as intended when used and, if necessary, be warned if the device has not achieved a valid result <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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      Usability Engineering Process<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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      The usability engineering process must not only cover the normal operation of the device, but also take into account transportation, storage, installation, maintenance, repair and disposal. In addition, after the medical device has been placed on the market, feedback from users and information about problems should be collected and evaluated in Post-Market Clinical Follow-Up (PMCF) and Post-Market Surveillance (PMS) in order to adapt and improve the usability of the product and safety information (e.g. warnings, operating instructions) if necessary.<\/p>\n

      The basis of usability engineering for medical devices is the IEC 62366-1 standard “Application of usability to medical devices”. IEC 62366-1 defines usability as “the property of the user-product interface that includes effectiveness, efficiency, ease of learning, and satisfaction of the user.” user.” IEC 62366-1 includes all the requirements for a usability-oriented medical device development process to develop user-friendly, safe, and ergonomic medical devices. The risks identified by the usability engineering with the use of the medical device are further analyzed, evaluated and controlled in the risk management according to ISO 14971. Usability engineering is therefore closely intertwined with risk management; together, the two processes ensure safe and effective medical devices. The process of usability engineering is documented in the usability engineering file.<\/p>\n

      We support you in implementing the requirements of the MDR and help you to create an IEC 62366-1 compliant usability engineering file.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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      Usability Engineering REGULATORY AFFAIRS under MDR Usability Engineering The usability engineering process is an important foundation in the development of safe and usable medical devices. The European Medical Device Regulation (MDR) 2017\/745 includes numerous requirements with regard to the usability and ergonomics of medical devices to reduce risks due to application errors by patients, users […]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":5361,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5405","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5405","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/comments?post=5405"}],"version-history":[{"count":11,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5405\/revisions"}],"predecessor-version":[{"id":6241,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5405\/revisions\/6241"}],"up":[{"embeddable":true,"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/pages\/5361"}],"wp:attachment":[{"href":"https:\/\/mec-abc.de\/en\/wp-json\/wp\/v2\/media?parent=5405"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}