SaMD (Software as a Medical Device) Interface Design
Pubrica’s SaMD interface design service supports SaMD and digital therapeutics companies, medical device manufacturers, diagnostic software companies and regulatory/quality teams with interface design documented to IEC 62366-1 / IEC TR 62366-2. Deliverables include the user interface specification, use-error and task-analysis documentation, formative and summative usability evaluation and a usability engineering file for submission. Our UX/UI designers, medical illustrators and 3D animators carry out the work in-house; a named subject specialist leads your project from brief to delivery, and a second, independent reviewer checks each deliverable before it reaches you.
- User interface specification covering intended users — included in every engagement
- Use-error and task-analysis documentation feeding the device risk management file — included in every engagement
- Formative usability evaluation reports across design iterations — included in every engagement
- Prepared to named standards, including IEC 62366-1 / IEC TR 62366-2
- Project-based pricing: we provide a written quote after a short scoping call
User interface specification covering intended usersIncluded
Use-error and task-analysis documentation feeding the device risk management fileIncluded
Formative usability evaluation reports across design iterationsIncluded
Summative usability study designIncluded
A fixed price before scopingNot included
Brief → scoping → draft → delivered
- User interface specification covering intended users
- Use-error and task-analysis documentation feeding the device risk management file
- Formative usability evaluation reports across design iterations
- Summative usability study design
- Usability engineering file assembled as certification/submission evidence
Deliverables
SaMD Interface Design Deliverables
Each deliverable below is prepared in-house by Pubrica’s medical illustrators, 3D animators and UX/UI designers.
Who We Serve
Organisations We Support with SaMD Interface Design
We support companies and teams that design, build or submit software used as a medical device.
Compliance and Standards
Compliance Standards for SaMD Interface Design
The usability, human factors and electronic records requirements that apply to SaMD interfaces.
IEC 62366-1 / IEC TR 62366-2
This is the core usability engineering standard for medical devices and SaMD, and it governs how user interface design, task analysis and use-error risk evaluation must be documented.
FDA Human Factors / Usability Engineering guidance
FDA expects summative human-factors testing with representative users for devices (including SaMD) where use error could cause harm, paralleling IEC 62366-1's requirements for the US market.
21 CFR Part 11
Where a SaMD interface captures or displays data used for regulatory records (e.g., audit trails, electronic signatures), the UI must support Part 11's requirements for electronic record integrity and authentication.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Pubrica’s certified quality management system governs how each project is run, reviewed and documented.
Responsible Use of AI
Our Approach to AI Use in SaMD Interface Design
We use generative AI tools only for drafting and iteration, and never where the output could be mistaken for verified clinical data or a real patient.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI design and content tools are usually reported by the vendors that sell them.
For this reason, we do not quote an accuracy figure of our own. We tell you which tool was used on your project, at which stage, and what the named reviewer changed afterwards.
Our Process
How a SaMD Interface Design Project Works
Each project follows four steps, with a draft review before final production so that any misunderstanding of the brief is corrected early.
Submit Your Brief and Reference Material
Tell us what the interface needs to support, who will use it and anything that must or must not appear, and send any existing assets, brand guidelines or source material we should work from.
Scoping Consultation
We confirm the audience and the applicable standards and, for scoped projects, the factors that determine the final quote.
Concept and First Draft
A subject specialist and the production team prepare the first version against the brief, and it is reviewed internally for accuracy before it is sent to you.
Revisions and Final Delivery
We incorporate your revisions and deliver the files listed on this page, including the working files, so the material can be updated later without starting again.
Request a Free Scoping Assessment for Your SaMD Interface
We confirm the cost, timeline and applicable standards before you commit. The assessment is free and takes two business days.
Our Experts
Your SaMD Interface Design Team
The same named team of specialists works on your project from scoping to delivery.
Determines what the work can claim on the basis of the evidence, and advises you clearly when the brief asks for something the evidence does not support.
Reviews the work independently of the first pass, with particular attention to factual accuracy. Any disagreements are logged and adjudicated by a third reviewer.
Responsible for file formats, compliance with the destination’s specification and the handover of working files, so that the delivered files match your brief.
Checks that each deliverable meets the standards that apply to it, such as MLR requirements, WCAG or the relevant regulatory guidance.
Evidence Base
Why SaMD Interface Design Matters
Each point below is drawn from published sources or from our team’s review practice. We can share the source or the responsible reviewer on request.
Packages
SaMD Interface Design Pricing Based on Project Scope
This service is priced after a short scoping call, because the cost depends on the factors listed below.
SaMD (Software as a Medical Device) Interface Design
The final price depends on the following factors.
Scoped quoteAfter a short, free scoping call
Delivery Set at scoping, typically 10–15 business days
- ✓Device risk classification and therefore depth of required usability evidence (formative-only vs. full formative + summative testing program)
- ✓Number of distinct user groups/use environments that must be analyzed (e.g., clinician vs. patient home use vs. caregiver)
- ✓Whether this is a net-new interface design or a usability remediation of an existing, already-marketed product
- ✓Target regulatory markets (FDA, EU MDR, both) and associated documentation formats required
- ✓Scope of testing required: number of summative usability study participants and iterations needed to close out identified use errors
Quality Assurance
Our Service Commitments
Our revision commitment, its limits and the remedy are set out before work begins.
Our revision commitment
Free Revisions Against the Agreed Brief and Named Standards
Within the agreed scope, we revise at no additional cost any work that does not match the brief or a standard named on this page.
01
The brief is confirmed before production
We confirm the brief at scoping so that any misunderstanding is resolved before production starts.
02
A named reviewer approves the work before delivery
The review is carried out against the standards listed on this page.
03
AI use is disclosed
We tell you which tool was used, at which stage, and what the reviewer changed afterwards.
04
Working files are handed over
You receive the working files, so the material can be updated later without starting again.
Client Testimonials
SaMD (Software as a Medical Device) Interface Design FAQs
Frequently Asked Questions About SaMD Interface Design
If your question is not answered here, please ask an expert. No quote is required.
Pubrica’s SaMD interface design service supports SaMD and digital therapeutics companies, medical device manufacturers, diagnostic software companies and regulatory/quality teams with interface design documented to IEC 62366-1 / IEC TR 62366-2. Deliverables include the user interface specification, use-error and task-analysis documentation, formative and summative usability evaluation and a usability engineering file for submission. Our UX/UI designers, medical illustrators and 3D animators carry out the work in-house; a named subject specialist leads your project from brief to delivery, and a second, independent reviewer checks each deliverable before it reaches you.
The core deliverable is a user interface specification covering intended users, tasks and use environments. The full list appears on this page under Deliverables.
Under IEC 62366-1, the usability standard used to support EU MDR compliance, manufacturers must produce a user interface specification with testable technical requirements, such as display legibility or alarm audibility, not just a general design direction.
Our specialists apply these published findings and the relevant regulatory guidance when planning and reviewing each project.
The cost depends on several variables: device risk classification and the resulting depth of usability evidence (formative-only vs. full formative + summative testing program); the number of distinct user groups and use environments to be analyzed (e.g., clinician vs. patient home use vs. caregiver); whether the work is a new interface design or usability remediation of an existing, marketed product; and the target regulatory markets (FDA, EU MDR, both) and documentation formats required.
A short scoping call allows us to quote accurately for your project before you commit.
SaMD and digital therapeutics companies commission it when preparing for FDA clearance or EU MDR certification.
Medical device manufacturers commission it when building companion apps or on-device software interfaces.
This is the core usability engineering standard for medical devices and SaMD, and it governs how user interface design, task analysis and use-error risk evaluation must be documented.
Our specialists apply this standard from the start of the project rather than correcting for it after review.
Related Services
Related Digital Health Experience Services
Other Digital Health Experience services, and related services elsewhere at Pubrica.
1SAME STAGEVisualize & design
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Further Reading on Visual Content Production
Request a Free Scoping Assessment for Your SaMD Interface
We confirm the cost, timeline and applicable standards before you commit. The assessment is free and takes two business days.