Data-driven UX agency for usability engineering, interface design and approval documentation in medical technology.
Custom Medical
Darmstadt · Boston (USA)New on Amplifa
About Custom Medical
Custom Medical is a UX design agency specializing in medical technology, in vitro diagnostics (IVD) and digital health, headquartered in Darmstadt with a branch office in Boston (USA). The company supports manufacturers of medical products throughout the entire development life cycle: from usability engineering and human factors, through formative and summative evaluations, user interface design (UX/UI) and IFU design, to release-ready software development with reusable UI components. In addition, Custom Medical produces approval-ready usability and technical documentation, including Usability Engineering Files, Human Factors Reports and Post-Market Surveillance (PMS). International user studies include study protocols, participant recruitment, moderation and root-cause analysis. The work follows a data-driven process (3DUX®) taking into account regulatory requirements under MDR and FDA as well as IEC 62366-1. Multiple awards such as the Red Dot Design Award and German Design Award attest to the design profile; the processes are ISO 13485 and ISO 27001 certified.
- Site
- Darmstadt
- Processes
- Usability Engineering & Human Factors (formative and summative evaluations), User Interface Design (UX/UI for software and hardware, IFU design), Software Development / Front-end Development (release-ready, reusable UI components), Usability/compliance documentation (Usability Engineering Files, Human Factors Reports, technical, International User Testing (study protocols, recruitment, moderation, root-cause analysis), Usability Engineering, Usability Testing (formative and summative evaluations), User Interface Design (UX/UI)
- Materials
- Data-Driven UX Design Process, Usability Engineering per IEC 62366-1, Software Development per IEC 62304
- Certificates
- ISO 13485, ISO 27001
- Employees
- 11-50
- Industries
- Medical Technology, In Vitro Diagnostics (IVD), Digital Health
- 01
Usability Engineering & Human Factors
- 02
UX/UI and IFU design
- 03
Formative and summative evaluations
- 04
Software development (front-end)
- 05
Approval documentation
- 06
Post-Market Surveillance (PMS)
Services & Methods
Data-Driven UX Design Process
Proprietary process that incorporates real user data and regulatory requirements into design decisions.
Usability Engineering per IEC 62366-1
Standards-compliant design and evaluation of user interfaces for medical devices.
Software Development per IEC 62304
Regulation-compliant software development with traceability and reusable UI components.
Locations
Darmstadt
DEHeadquarters
Boston
USBranch office (One Boston Place, Suite 2600)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Usability Engineering & Human Factors (formative and summative evaluations)Testing | – | – | – | – | – |
| User Interface Design (UX/UI for software and hardware, IFU design)Engineering | – | – | – | – | – |
| Software Development / Front-end Development (release-ready, reusable UI components)Engineering | – | – | – | – | – |
| Usability/compliance documentation (Usability Engineering Files, Human Factors Reports, technicalEngineering | – | – | – | – | – |
| International User Testing (study protocols, recruitment, moderation, root-cause analysis)Testing | – | – | – | – | – |
Additional services
Quality & Certification
The processes are certified according to ISO 13485 (medical devices) and ISO 27001 (information security) and align with MDR and FDA requirements as well as IEC 62366-1.
| Evidence | Darmstadt |
|---|---|
| ISO 13485 | |
| ISO 27001 |