Health & life sciences
Every claim, screen and update must match what was approved.
For makers of devices, diagnostics and software as a medical device, we design clinician and patient interfaces and regulated product sites. Each comes with the documentation, data and AI governance regulators in India, the EU and the US expect.
Where the rules biteMap of all forty-one industries
What is shifting
Licensing for every device class in India, draft guidance on device software, an EU date for AI duties and a marketing code for devices. Each lists what it demands, with a dated source.
What it requiresLabels, instructions, product sites and promotion that match the licensed intended use.
EvidenceUnder the Medical Devices Rules, 2017, class A and B devices came under licensing from 1 October 2022, and class C and D devices from 1 October 2023.
What it requiresRisk classification, design controls and change plans for software from the first sprint.
EvidenceCDSCO published draft guidance on medical device software on 21 October 2025, covering software that is a device and software within one.
What it requiresDocumentation, data governance and human oversight for AI features, planned before market entry.
EvidenceThe EU’s 2026 Digital Omnibus set 2 August 2028 for AI Act high-risk duties on AI that is part of products such as medical devices.
What it requiresClaims, events and samples designed to the code, with a complaints route published.
EvidenceThe Department of Pharmaceuticals introduced the Uniform Code for Marketing Practices in Medical Devices on 6 September 2024.
The rulebook
India’s Medical Devices Rules and marketing code, the EU device and AI rules and US guidance on AI-enabled software, summarised for a typical programme. Your regulatory and quality teams keep sign-off.
Frameworks we build to
We design and build to these frameworks; this is not a claim of certification.
Shapes most of the work
Department of Pharmaceuticals
No promotion before approval, and claims must match the approved product information; gifts and hospitality for healthcare professionals are barred.
We designEvery page, brochure and talk draws on a claims library mapped to the licensed intended use.
Department of Pharmaceuticals · UCMPMD, introduced 6 September 2024
Shapes most of the work
CDSCO, Ministry of Health
Devices are classed A to D by risk and every class now needs a licence; software intended for diagnosis, monitoring or treatment is regulated as a device.
We designInterfaces, labels and instructions are designed to the intended use the licence records.
Medical Devices Rules, 2017 · licensing for class A and B from 1 October 2022, class C and D from 1 October 2023
CDSCO, Ministry of Health
Draft guidance sets out how software that is a device, or part of one, is classified by risk and licensed, including how AI models may change after approval.
We designSoftware is specified with its risk class, evidence and change plan before the first release.
CDSCO · draft guidance document on Medical Device Software, 21 October 2025
European Union
Devices for the EU need conformity assessment under the MDR. Under the 2023 extension, certificates issued under the old directives can stay valid until 31 December 2027 or 31 December 2028, depending on class.
We designTechnical documentation and labelling are structured once and versioned per market.
Regulation (EU) 2017/745, as amended by Regulation (EU) 2023/607 Official text: EU Medical Device Regulation
Shapes most of the work
Ministry of Electronics and IT
Readings, images and device data collected per purpose with consent, withdrawal as easy as consent, and breach reporting to the Data Protection Board.
We designDevice apps collect only what the clinical purpose needs, with consent logged per purpose.
DPDP Act, 2023 · DPDP Rules, 2025 (core obligations from 13 May 2027) Official text: DPDP Act, 2023 and DPDP Rules, 2025
Shapes most of the work
Indian Computer Emergency Response Team
Cyber incidents reported to CERT-In within six hours of being noticed, and ICT logs kept for 180 days.
We designConnected devices and portals launch with logging, monitoring and an incident runbook.
CERT-In · Directions under section 70B(6), 28 April 2022 Official text: CERT-In Directions, 2022
Shapes most of the work
European Union
AI that is a safety component of a device needing notified-body assessment is high-risk; under the 2026 Digital Omnibus those duties apply from 2 August 2028.
We designAI features get documentation, data governance, logging and human oversight from the first design.
Regulation (EU) 2024/1689 · Article 6(1), as amended by Regulation (EU) 2026/1744 Official text: EU AI Act — AI in medical devices
US Food and Drug Administration
Makers can describe planned modifications to AI-enabled device software, with the methods and assessments behind them, in the original marketing submission.
We designEvery AI feature launches with a written plan for how it may change and how each change is tested.
FDA · final guidance on Predetermined Change Control Plans for AI-Enabled Device Software Functions, 4 December 2024 Official text: US FDA guidance on change control plans for AI
Compiled 3 October 2026. Our reading of typical programmes, not legal advice. Rules change; your counsel confirms how each one applies to you.
Challenges
The problems that come up in most medical devices & diagnostics programmes, for customers and for your teams.
Interfaces that surface the right reading and alarm without adding clicks to a shift.
Set-up, readings and alerts that make sense without a nurse in the room.
Clear limits on what an algorithm does, and when to call a clinician.
What we build
A typical programme here uses each discipline in this mix. Each line says what it builds for the industry and links to the capability behind it.
Device apps, data platforms and secure cloud services built with design controls and audit trails.
Clinician and patient interfaces designed to the intended use, with usability testing built in.
Product launches and clinician education kept inside the approved claims.
AI features with evaluation sets, change plans and clinician oversight designed in.
Portfolio brands and labelling templates with room for every regulated mark and instruction.
Clinician engagement and service journeys on one consented record.
Programmes
The review ranks fixes by approval risk and records your baseline. Each later programme has its own agreed measure. Durations are typical, not promised.
The way in
We check your claims, labelling, interface and software change process against each market’s device rules, and rank the fixes by approval risk.
What you get
02Milestone · 4–9 months
A patient app and clinician dashboard designed and built under design controls, with usability evidence and traceable requirements.
MeasureUse errors found in summative usability testing
Services: Complete UX & UI design · Web or mobile app · Custom CRM or operations platform
Enquire about Device app and clinician dashboard03Project · 8–12 weeks
An AI feature specified with its evaluation set, performance limits, human oversight and a plan for how it may change after approval.
MeasurePerformance on the agreed evaluation set
Services: Brand fidelity evaluation · AI feature design & build
Enquire about AI feature with an evaluation set and change plan04Project · 6–10 weeks
A product site and claims library that keep every page, brochure and talk inside the approved intended use, market by market.
MeasureShare of promotional claims mapped to the approved intended use
Services: Website · Content model & headless CMS · Brand check
Enquire about Regulated product site and claims libraryHow success is measured
Main measureTime from design change to approved release
AI, under the rules
Each use has an owner, an evaluation set, a change plan and a log, and no model output reaches a patient without a clinician.
Use case 01
Measured bySensitivity and specificity on the agreed evaluation set
Tested forOWASP LLM06 · Excessive agency
Goes live only with its evaluation set, automatic checks and a named owner
Use case 02
Measured byReports routed within the agreed time
Tested forOWASP LLM02 · Sensitive information disclosure
Goes live only with its evaluation set, automatic checks and a named owner
Use case 03
Measured byReview cycles per document
Tested forOWASP LLM09 · Misinformation
Goes live only with its evaluation set, automatic checks and a named owner
Work and insights
We publish medical devices & diagnostics projects only once a client signs off the write-up. Meanwhile, here is the reading that applies.
A typical programme · composite
A diagnostics company rebuilt its device app and clinician dashboard around the licensed intended use. A change plan covers its algorithm, and a claims library keeps every brochure, page and talk within the approval.
Anonymised and illustrative: the shape a programme takes, never a named client.
Nothing published on medical devices & diagnostics yet. Ask us what we are seeing in the industry.
Ask usQuestions
Something else on your mind? Ask us directly
It may be. In India, the EU and the US, software intended to diagnose, monitor, treat or prevent disease can be regulated as a device. We help you write the intended use precisely and design within it. Classification and any licence application stay with your regulatory team.
Yes. We work inside your quality system. Requirements are traced to designs and tests, and usability testing feeds your risk file. Documentation follows the form your auditors expect.
We release a fixed, evaluated version with a written change plan. The plan sets what may change, how each change is tested and when it needs approval. It is written in line with the US FDA’s guidance on change control plans and the EU AI Act. Nothing changes in the field without it.
Yes: we also design clinician-facing tools and portals for providers. Our page on hospitals and care providers covers that work.
Keep exploring
You will speak to a lead who would run the work, and get a straight answer on fit.
01About 2 minutes
You get A reply from a named lead
02About 8 minutesRecommended
You get Options and a first scope after one call
03About 15 minutes
You get Receipt confirmed and a named bid lead
Every engagement starts with a written scope and a quote agreed before work begins. How each package is priced
