Custom Medical
Custom Medical is a data-driven UX design agency specializing in outstanding user interface design for medical devices. They have won multiple awards including the Red Dot Design Award and the German Design Award. Their services include usability engineering, user interface design, documentation, testing, and development of user interface components to meet regulatory standards such as MDR, FDA, ISO 13485, and ISO 27001. They focus on integrating real user data into the design process to create safe, easy-to-use, and delightful medical products, emphasizing meticulous documentation, iterative design, and compliance with standards like IEC 62366-1. They also offer specialized services in IFU design and testing, gap analysis for technical documentation, and support for summative usability evaluations, ensuring compliance with MDR and IVDR requirements.
Industries
Nr. of Employees
small (1-50)
Custom Medical
Darmstadt, Hessen, Germany, Europe
Products
Guide: How to Design Compliant Medical/Health User Interfaces
Downloadable guide covering principles and practical steps for designing compliant and usable medical user interfaces.
Decision tree: UI/UX billing model selection (PDF)
Decision tree PDF to help choose between fixed price, hourly and flat-rate billing models for medical UI/UX projects.
Guide: How to Design Compliant Medical/Health User Interfaces
Downloadable guide covering principles and practical steps for designing compliant and usable medical user interfaces.
Decision tree: UI/UX billing model selection (PDF)
Decision tree PDF to help choose between fixed price, hourly and flat-rate billing models for medical UI/UX projects.
Services
Iterative user research and prototype testing to inform design and reduce use-related risk early in development; includes participant recruitment, contextual analysis and documentation for the use specification.
Regulatory-aligned validation studies including test planning, selection of critical tasks and participants, execution in lab or remote settings and preparation of validation reports for submissions.
Design of medical device user interfaces focusing on task alignment, information hierarchy, visual design and iterative optimisation; includes design system creation and component specification.
Product and interaction design services that integrate usability engineering, risk assessment and regulatory requirements into product concepts and prototypes.
Authoring and usability-testing of Instructions for Use to ensure clarity and task support for intended users; deliverables include multi-language IFUs and reusable design element libraries.
Implementation of validated front-end software including UI components, secure coding practices, automated test suites, performance optimisation and managed handover of source code and development documentation.
Iterative user research and prototype testing to inform design and reduce use-related risk early in development; includes participant recruitment, contextual analysis and documentation for the use specification.
Regulatory-aligned validation studies including test planning, selection of critical tasks and participants, execution in lab or remote settings and preparation of validation reports for submissions.
Design of medical device user interfaces focusing on task alignment, information hierarchy, visual design and iterative optimisation; includes design system creation and component specification.
Product and interaction design services that integrate usability engineering, risk assessment and regulatory requirements into product concepts and prototypes.
Authoring and usability-testing of Instructions for Use to ensure clarity and task support for intended users; deliverables include multi-language IFUs and reusable design element libraries.
Implementation of validated front-end software including UI components, secure coding practices, automated test suites, performance optimisation and managed handover of source code and development documentation.
Expertise Areas
- Usability engineering and human factors for medical devices
- Human factors validation and summative usability evaluation
- Integration of usability with risk management (ISO 14971)
- Formative user research and participant recruitment
Key Technologies
- Usability testing (formative and summative)
- IEC 62366-1 usability engineering methods
- Use-related risk analysis (FDA human factors / ISO 14971 integration)
- User research methods (interviews, contextual inquiry, observations)
News & Updates
An in-depth analysis of the new transition periods for medical devices under MDR, including deadlines and regulatory requirements.
Explains the relationship between risk management and usability engineering in medical device development.
Details the process for evaluating user interfaces of unknown provenance according to IEC 62366-1.
Comprehensive information on Human Factors Reports and their importance in medical device approval.
Guidance on usability engineering requirements for sterile medical devices.
A checklist to prepare for summative usability evaluations in medical device approval.
An in-depth analysis of the new transition periods for medical devices under MDR, including deadlines and regulatory requirements.
Explains the relationship between risk management and usability engineering in medical device development.
Details the process for evaluating user interfaces of unknown provenance according to IEC 62366-1.
Comprehensive information on Human Factors Reports and their importance in medical device approval.
Guidance on usability engineering requirements for sterile medical devices.
A checklist to prepare for summative usability evaluations in medical device approval.