Custom Medical

medical devices

About

Custom Medical is a usability and UX design agency that specializes in medical devices and in vitro diagnostics (IVDs). The company focuses on user interface design, usability engineering, documentation, and testing tailored specifically for the medical industry. They employ a data-driven approach to ensure optimal user experiences and compliance with regulatory standards. Their services include creating intuitive interfaces, conducting usability evaluations, preparing regulatory documentation, and supporting compliance with European and U.S. regulations. Custom Medical has received multiple awards, including the Red Dot Design Award and the German Design Award in 2023, reflecting their commitment to excellence in design. The company operates under a TÜV-certified quality management system according to ISO 13485. They primarily serve manufacturers of medical devices and IVDs, offering expert support in usability and regulatory documentation to help bring compliant, user-friendly products to market.

Technologies

Outlook Microsoft Office 365 Teachable Kajabi Mapbox Nginx DoubleClick Conversion DoubleClick Google Tag Manager Mobile Friendly Google Dynamic Remarketing WordPress.org Active Campaign Vimeo Gravity Forms Google Font API

Keywords

usability engineering usability testing iec 623661 summative evaluation formative evaluation user interface design medical devices medical device usability medical device user experience medical equipment manufacturing medical device design design awards human factors validation frontend development for medical devices data driven ux design (3dux) iec 62366-1 iso 27001 b2b product development human factors engineering ux design post-market surveillance iso 13485 healthcare equipment and supplies manufacturing fda medical usability lab software development in healthcare mdr services regulatory documentation

Location

7 Robert-Bosch-Strasse, Darmstadt, Hesse, Germany, 64293

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