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Reliable Software for Devices Where Accuracy Matters.
We build companion apps, device connectivity, and data platforms for medical device manufacturers and healthtech companies, engineered for reliability, traceability, and the documentation that regulated products require.
Trusted by teams building what's next
Medical devices increasingly depend on software: companion apps that guide patients, cloud platforms that store readings, clinician portals that turn data into decisions, and standalone Software as a Medical Device. That software sits inside a regulated product, so it has to be dependable on every supported phone, secure against modern threats and documented well enough to stand up to an auditor, a notified body or the FDA.
As a medical device software development company, we build BLE companion apps, device connectivity layers, cloud data platforms, clinician dashboards and SaMD components for device manufacturers and healthtech companies. We work inside your quality management system, following an IEC 62304-aligned lifecycle with requirements traceability, risk controls linked to ISO 14971 analysis, and verification evidence produced as part of every sprint.
Connectivity is where many device programmes slip. We engineer pairing, reconnection, background sync and firmware update flows across iOS and Android versions, using Bluetooth LE health profiles where devices support them. Data flows through AWS IoT or Azure IoT Hub into platforms that integrate with Epic, Oracle Health (Cerner) and other EHRs through HL7 v2 and FHIR R4, with 21 CFR Part 11 controls where electronic records require them.
Cybersecurity and regulatory documentation are designed in, not assembled at the end. We support FDA SaMD and premarket cybersecurity expectations, EU MDR technical documentation, IEC 81001-5-1 secure lifecycle practices and ISO 13485 records, alongside HIPAA, GDPR and regional data rules. Your regulatory team stays responsible for classification and submissions, and we give them the evidence they need.
Software development plans, requirements, architecture, unit and integration verification, and release records produced within your QMS, with traceability maintained as the product changes.
Pairing, bonding, reconnection, background sync and data integrity checks engineered and tested across a matrix of iOS and Android devices and OS versions.
Software risk controls traced to ISO 14971 analysis, threat modelling, SBOMs and secure update mechanisms that support FDA premarket and IEC 81001-5-1 expectations.
Secure ingestion through AWS IoT or Azure IoT Hub, device fleet management, data storage with audit trails and APIs for clinicians, partners and EHRs.
We work alongside your embedded team on protocols, GATT services, OTA update flows and test fixtures, so device and app releases stay compatible.
Versioned requirements, impact analysis, regression evidence and release documentation for every change, so post-market updates do not reopen the whole file.
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Countries with live products
Each one designed with your teams, integrated with the systems you already run, and engineered to scale.
iOS and Android apps that pair with devices and guide patients.
BLE, Wi-Fi, and gateway integrations with robust error handling.
Secure ingestion, storage, and processing of device readings.
Web portals for reviewing patient data and alerts.
Working with your firmware team on protocols and updates.
Requirements traceability, verification testing, and documentation support.
Other healthcare areas with a dedicated page.
The product categories medical device software organisations most often ask us to build, from focused mobile apps to multi-tenant platforms.
Standalone software that performs a medical purpose, such as analysis, monitoring or decision support, developed within your regulated lifecycle.
iOS and Android apps that pair with glucose meters, blood pressure monitors, inhalers, pumps and other devices to capture and explain readings.
Ingestion, storage, fleet management and APIs for device data, with audit trails and role-based access.
Web applications where care teams review device data, thresholds and alerts for their patient population.
Apps for technicians and field engineers to configure, calibrate, diagnose and update devices securely.
Signed over-the-air updates, version tracking and staged rollouts for devices in the field.
Viewing, measurement and workflow software for diagnostic devices, integrated with PACS through DICOM.
Data capture and export for device studies, with 21 CFR Part 11 controls for electronic records and signatures.
Grouped by who uses them. Every feature below is one we have shipped to production, not a wishlist.
Guides patients through using the device correctly.
From raw readings to clinical decisions.
Fleet, release and post-market oversight.
The problems we most often help medical device software organisations solve, and design every engagement around.
Software must be planned, traceable, verified and documented to a standard that supports FDA, EU MDR and other submissions, not reconstructed after development.
Bluetooth behaviour varies across phone models, OS versions and power-saving modes, and dropped connections can mean lost or duplicated clinical readings.
Regulators now expect threat models, SBOMs, vulnerability management and secure update mechanisms as part of the device submission and post-market plan.
Device data needs protection from sensor to clinical use, with integrity checks, access control and audit trails at every step of the pipeline.
OS updates, new phones and feature requests keep arriving after launch, and each change needs impact analysis and evidence without stalling the roadmap.
Real products designed and engineered by Creuto end to end, with the operational depth healthcare and medical device software projects demand.
A full-stack beauty marketplace consumer mobile app, vendor dashboard, and super admin panel designed and delivered by Creuto from scratch.
200+
Vendors Onboarded
40%
Drop-offs Reduced
16 wk
Time to Market
A full-stack workflow management platform — admin panel, task boards, collaboration engine, and reporting suite — designed and delivered by Creuto from the ground up.
1
Source of Truth for All Work
100%
Task Audit Trail
4
Task Lifecycle States
A cloud-native, IoT-powered smart city platform — web command dashboard, citizen mobile app, field staff app, and full IoT integration designed and delivered by Creuto from the ground up.
10
Integrated Modules
25–30%
Reduction in Vehicle Trips
4
Platforms Delivered
The medical device software standards we build against and the controls behind them. Your compliance team keeps ownership; we make the software easy to certify.
The platforms, standards and third-party services a product in this sector usually has to talk to. If yours is not listed, it is almost certainly something we have connected before.
The reasons clients in this sector give when they recommend us, not the ones we would pick ourselves.
Either we build it exceptional, or we don't.
The standard every medical device software product leaves our studio with.
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Products delivered
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Years of engineering
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Client satisfaction
Our deliverables follow your procedures and templates, so evidence slots into your design history file without rework.
We have solved the pairing, background and reconnection issues that make BLE companion apps unreliable on real phones.
Requirements, risks, code and tests are linked continuously, so audits and submissions are not a last-minute scramble.
Threat modelling, SBOMs, signed updates and vulnerability management are part of the architecture, not a pre-submission patch.
Your regulatory team owns classification and submissions. We provide the engineering, evidence and support they need to do that well.
What organisations in this sector gain when the software is built around their workflows rather than the other way around.
Traceable requirements, risk controls and verification evidence reduce questions and rework during regulatory review.
Reliable pairing, clear error guidance and automatic sync reduce the device support burden on your team.
Companion apps that explain readings and remind patients help people use the device as intended.
Integrity checks, provenance and audit trails make device data suitable for clinical decisions.
Controlled change processes let you ship OS compatibility updates and features without reopening the whole file.
Connected platforms enable remote monitoring programmes, data services and subscriptions around the device.
Transparent, sprint-based and built around decisions you can see. You know what ships, when, and why at every step.
Start Your ProjectWe clarify intended use, users, device interfaces and the regulatory route with your team, and agree how our work fits your quality management system.
Software development plan, architecture, safety classification inputs, ISO 14971 risk controls and the cybersecurity threat model are documented before build begins.
Interfaces are designed and tested following IEC 62366-1 principles, with formative evaluations involving representative patients and clinicians.
Two-week sprints where every requirement, risk control and test is linked, and verification evidence is produced alongside the code rather than afterwards.
Automated and manual verification, device compatibility matrix testing, penetration testing and release documentation ready for your design history file.
Controlled releases, OS compatibility monitoring, vulnerability management and change impact analysis keep the product compliant after launch.
Chosen per project for longevity, hiring depth and fit with your existing systems, never by fashion.
AI IN MEDICAL DEVICE SOFTWARE
We build AI features for device software with the controls regulated products need: documented training data, locked or planned model changes, performance monitoring and clinician review where outputs inform care.
Explore our AI engineeringThe shifts we design for so a product launched this year is still the right product in three.
Regulators expect threat models, SBOMs and vulnerability management plans in premarket submissions, making secure lifecycle practices mandatory.
Devices increasingly feed remote patient monitoring programmes, so companion apps and cloud platforms carry more clinical responsibility.
Machine learning features in devices bring new expectations around data management, performance monitoring and planned model changes.
FDA's Quality Management System Regulation now aligns US requirements with ISO 13485, simplifying quality processes for manufacturers selling in several markets.
More therapies rely on the patient's own smartphone, which makes OS compatibility monitoring and rapid validated updates a core capability.
There is no honest single number. Scope, integrations and compliance drive the budget, so we price against a written scope after discovery. The factors below are what move it.
Higher IEC 62304 safety classes require more detailed design, verification and documentation.
Companion app, clinician portal, cloud platform and manufacturer console each add design, build and verification.
Custom BLE protocols, multiple devices and OTA updates add engineering and compatibility testing effort.
FDA, EU MDR and other markets add documentation and evidence specific to each submission.
Threat modelling, SBOMs, penetration testing and vulnerability management are sized by device risk and connectivity.
EHR, cloud IoT, eQMS and partner systems each add mapping, sandbox access and verification.
| Engagement | Typical scope | Timeline |
|---|---|---|
| Validation MVP | Companion app or prototype SaMD with one device, basic cloud sync and design controls for feasibility. | 10 to 14 weeks |
| Production platform | Companion app, clinician portal and cloud platform with full traceability, security and verification evidence. | 4 to 7 months |
| Multi-device or multi-market | Device family, fleet management, OTA updates, EHR integration and evidence for several markets. | 8 to 14 months, phased |
Revenue models we have built billing, reporting and growth loops for. Most products combine two or three.
Software included in the device price, with premium features or data services as paid upgrades.
Recurring fees for coaching, advanced insights or supplies linked to the companion app.
Providers bill eligible remote monitoring services using device data, supported by the platform's reporting.
Per-clinic or per-patient fees for portals and dashboards used by care teams.
De-identified, consented data services for research and product improvement where regulation permits.
The engineering disciplines every project in this sector draws on. Each has its own page with process, stack and FAQs.
Founders and product leaders on what it is like to build with Creuto.
“Their services were excellent.”
Creuto delivered a web and mobile app that exceeded the client's expectations. The team was highly responsive and punctual from a workflow standpoint, and internal stakeholders praised the service provider's collaborative nature and agility.
Emma Richardson
CEO, Emion
More client voices
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Straight answers about medical device software software projects. If yours is not here, ask us directly.
Ask our medical device software teamIt depends on the software safety class, the number of apps and platforms, device connectivity complexity, the regulatory markets you are targeting, cybersecurity scope and integrations. A feasibility MVP is a much smaller investment than a multi-market device platform. After discovery we provide a fixed-scope proposal with a clear breakdown.
A validation MVP with a companion app or prototype SaMD typically takes 10 to 14 weeks. A production platform with companion app, clinician portal, cloud and full verification evidence usually takes four to seven months. Multi-device or multi-market programmes are delivered in phases over eight to fourteen months.
Yes. We work within your quality management system following an IEC 62304-aligned lifecycle, link software risk controls to your ISO 14971 analysis, support ISO 13485 records and provide requirements traceability, verification evidence and release documentation for FDA, EU MDR and other submissions.
Yes. We route device data through AWS IoT or Azure IoT Hub into platforms that integrate with Epic, Oracle Health (Cerner) and other EHRs using HL7 v2 or FHIR R4, with Mirth Connect or HAPI FHIR where an integration layer is needed.
App development usually refers to the companion mobile app that pairs with a device. Medical device software development covers the full system: embedded interfaces, apps, cloud platform, clinician tools, cybersecurity and the lifecycle documentation regulators expect. We deliver both, within one traceable process.
Yes, in partnership with your regulatory team, who remain responsible for classification and submissions. We follow FDA SaMD guidance and EU MDR expectations for software, and deliver the plans, traceability, risk controls and verification evidence your technical file needs.
Yes. We build BLE companion apps for iOS and Android with careful handling of pairing, bonding, reconnection, background behaviour and data integrity, tested across a defined device and OS matrix, and using Bluetooth LE health profiles where your device supports them.
We threat-model the system, produce SBOMs, sign firmware and app updates, encrypt data from device to cloud and run penetration tests before release. After launch we monitor vulnerabilities and support a disclosure process, in line with FDA premarket cybersecurity expectations and IEC 81001-5-1.
Tell us what you are building. We will help you scope it, design it, and ship it, with a senior team accountable end to end.
