{"id":65,"date":"2019-01-29T09:59:02","date_gmt":"2019-01-29T09:59:02","guid":{"rendered":"https:\/\/www.garza.nu\/?page_id=65"},"modified":"2019-02-05T10:27:05","modified_gmt":"2019-02-05T10:27:05","slug":"usability","status":"publish","type":"page","link":"https:\/\/www.garza.nu\/?page_id=65","title":{"rendered":"Requirements and Usability"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\">Usability<\/h3>\n\n\n\n<p>One of the key competences of Garza MD is the usability engineering process. This not only because of a university background of the consultant in product design but also because of a 10-years working experience in this field.<br><\/p>\n\n\n\n<p>The usability engineering process needs to be flexible and documented. Traceability is a mandatory requirement required. And the &nbsp;The process can be scaled according to your needs. Garza MD can advice and guide you in this process and customize it to your needs specific situation. <\/p>\n\n\n\n<p>EN 62366 sets out a usability engineering process for medical devices that helps to design straightforward and efficient user interfaces. These, in turn, will minimize user errors and hence reduce risks. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Requirements engineering<\/h3>\n\n\n\n<p>Garza MD offers support for setting up the required documents for the design history file of a medical device. This includes traceability of requirements and requirement changes, tests, verification and validation. Garza MD can also support in the implementation and application of a&nbsp;lifecycle management software tool (e.g. requirements management). <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Software lifecycle<\/h3>\n\n\n\n<p>Software is often, if not always, an integral part of an active medical device, or it can be a medical device of its own.<\/p>\n\n\n\n<p>Garza MD has many years of experience with medical software projects. Garza MD can support in the setting up of a software development process based on EN 62304 and \/ or EN ISO 13485 .<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Usability One of the key competences of Garza MD is the usability engineering process. This not only because of a university background of the consultant in product design but also because of a 10-years working experience in this field. The usability engineering process needs to be flexible and documented. Traceability is a mandatory requirement required. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-65","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Requirements and Usability - Garza MD<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.garza.nu\/?page_id=65\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Requirements and Usability - Garza MD\" \/>\n<meta property=\"og:description\" content=\"Usability One of the key competences of Garza MD is the usability engineering process. This not only because of a university background of the consultant in product design but also because of a 10-years working experience in this field. The usability engineering process needs to be flexible and documented. Traceability is a mandatory requirement required. 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