Medical device software product design services
Design safe and user-centred medical UX, from early concept to clinical trial-ready MVPs, embedded devices, and scalable digital products. Our solutions integrate Medical Device Regulation compliance, ISO 14971 risk management, IEC 62366 usability engineering, and EAA accessibility demands.
Why us
Working with us gives you a full lifecycle medtech partner, guiding you from discovery, through MVP, to clinical-ready solutions. Our medical device software product design services cover embedded, mobile, and web interfaces, enabling you to deliver a broad range of medical software products with confidence. We combine user-centered design, rigorous usability engineering, and a risk-based approach to minimise clinical risk, prevent costly reworks, and ensure audit readiness.
We can help you with:
Strategy & Product Discovery:
- discovery & intended use definition
- clinical workflow optimisation
- medical product design
Interface Design & Prototyping:
- UI for medical software and hardware
- MVP ready for clinical trials
- clickable prototypes
Regulatory Compliance:
- user testing & evaluation
- accessibility & inclusive design
- usability engineering
- risk-based design
Medical device software product design services
Discovery & Intended Use defining
Shaping medical product concept & design
Making clickable prototype for market validation
Delivering an MVP ready for clinical trials
Designing UI for Software as a Medical Device
Building UI embedded in medical devices
Conducting user testing & evaluation
Auditing clinical workflow
Creating inclusive & accessible design
Discovery & Intended Use defining
To minimise delays and reworks, we define the medical device’s purpose, user profile, and regulatory scope upfront, supporting strategic decision-making and business objectives alignment.
This step ensures applicable regulatory obligations (MDR, IVDR, FDA) are met, integrates risk management (ISO 14971), and provides a foundation for usability engineering (IEC 62366-1) with human factors in mind.
Shaping medical product concept & design
We translate your business vision into a functional product concept and development roadmap, ensuring technical feasibility and supporting business strategy from day one.
Together with the client, we define a Minimum Viable Product (MVP) with core functionalities, design workflows, and produce a development strategy which incorporates a risk-based approach and implements appropriate risk control measures (ISO 14971).
Making clickable prototype for market validation
Our goal is to deliver a clickable prototype ready for market validation, accelerating time-to-evidence and supporting investment decisions.
We create interactive, human factors focused clickable prototypes in tools such as Figma. This way we enable user tests, presentations for stakeholders, and risk-free iteration before any code is written.
Delivering an MVP ready for clinical trials
We provide an early-version of a technically stable product able to collect clinical data, allowing you to validate medical efficacy.
Building MVP suitable for clinical testing, we ensure compliance with relevant standards (e.g., IEC 62366-1, ISO 14971) and optimise scalability so the final product can be safely extended.
Designing UI for Software as a Medical Device
We create scalable visual systems for Software as a Medical Device (web & mobile), reducing development time, ensuring brand consistency, and supporting faster product scaling.
By using reusable components across web and mobile frameworks, we limit technical debt, enable rapid prototyping and testing, and maintain accessibility and risk management requirements.
Building UI embedded in medical devices
We design interfaces for physical medical devices screens, modernising legacy hardware to match users’ expectations, improve usability and responsiveness, and increase market competitiveness.
Our team optimises user-friendliness, turning animations, icons, and visual elements for smooth performance, minimising input-to-response latency. Also, we align UI with IEC 62366-1 usability standards and relevant risk control measures.
Conducting user testing & evaluation
We help you demonstrate that your medical device is safe and usable, reducing regulatory risk, avoiding costly redesigns, and enabling a predictable path to market.
By conducting formative usability evaluations in line with IEC 62366-1, we generate the empirical evidence required by notified bodies for MDR conformity assessments and document it in a Usability Engineering File (UEF).
Auditing clinical workflow
We help medical devices fit into real-world settings, reducing cognitive load on healthcare professionals, lowering the risk of errors, and increasing product adoption in clinical environments.
Our specialists audit clinical workflows, analysing how healthcare professionals interact with the medical device and identifying interface improvements that respect medical staff’s limited time.
Creating inclusive & accessible design
We design medical devices that are accessible by default, so you can reach a broader audience, support users with diverse needs, and unlock opportunities such as insurance reimbursement.
We design and validate interfaces in line with WCAG (Web Content Accessibility Guidelines) 2.2 and the EAA (European Accessibility Act), reducing legal and compliance risks.
Case studies
Check out how our medical device software product design services helped medical software companies create usable, safe, and compliant products, while meeting usability engineering and risk management requirements:
About Revolve Healthcare:
A regulatory-first software development partner for medical device software.
Our integrated process supports full design control, usability engineering, verification, and traceability as expected by legal manufacturers and notified bodies.
We operate within an ISO 13485-certified QMS and use our Scrum 62304 framework, aligning Agile delivery with IEC 62304, ISO 14971, and IEC 62366.
We have contributed to more than ten MDR- and IVDR-aligned software initiatives, covering product discovery, UX design, software development, code refactoring, and documentation remediation.
Contact us
Schedule a strategic consultation with our product design and regulatory experts.
During the session, we can:
review your product design and usability challenges
clarify MDR or IVDR expectations
define a realistic path toward a functional, compliant product
address questions around usability engineering, user testing, and accessibility
The 45-minute session is exploratory and non-binding, designed to help you make informed decisions.