Can you build companion apps for our medical devices?

Yes. We specialize in apps that sync with wearables, monitor real-time vitals, and integrate with cloud-based dashboards.

How long does it take to build a medtech software MVP?

A focused companion app or MVP typically goes live in 8–12 weeks, depending on the device, integrations and documentation needs. Full SaMD-grade platforms take longer because of the verification, validation and traceability work.

Are your solutions compliant with healthcare and medical device regulations?

Yes. We build to an IEC 62304 software lifecycle with ISO 14971 risk management, ISO 27001-compliant security practices, and HIPAA and GDPR-ready data handling. We work inside your quality system. Regulatory submissions and certification stay with your quality and regulatory team or an independent regulatory partner we work with, which keeps the assessment unbiased.

Can you integrate with existing pharma or device systems?

Absolutely. We offer API-based integrations with CRMs, ERP systems, eCommerce platforms, and lab software.

What should I look for in a medical device software development company?

Look for proven regulatory experience (FDA, HIPAA, GDPR, MDR, ABHA), a track record with connected devices and SaMD, and a team that treats compliance as part of the build, not an afterthought. We've delivered wearable, diagnostic, and pharma platforms for medical device manufacturers across 14 countries, with audit trails and secure architecture built in from day one.

How much does it cost to build medical device software?

A device companion app MVP starts from around $25,000 and typically takes 8–12 weeks. A SaMD-grade platform with a full IEC 62304 lifecycle, risk management and verification typically runs $60,000–$150,000, and enterprise multi-device platforms $150,000–$350,000+. Regulatory submissions and certification are separate. Share your device and intended use and we will scope and price your build.

Do you offer ongoing medical device software development services after launch?

Yes. Our medical device software development services don't stop at delivery, we offer full lifecycle support: feature upgrades, maintenance, scaling, and performance optimization.

Can your software scale globally across markets and teams?

Yes. Our architecture is built to support multilingual interfaces, multi-region deployment, and modular feature rollouts.

Medical Device Software Development

Medical Device Software, Built to IEC 62304

As a medical device software development company, we build SaMD, connected-device and companion-app software under an IEC 62304 lifecycle with ISO 14971 risk management, plus the cloud, pharma and commerce platforms around your device.

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Medical Device Software We Build

From the app in your customer’s hand to the cloud platform behind the device, these are the software layers we build most often for device makers and digital health product teams.

Companion apps for connected devices

iOS and Android apps that pair with your device over Bluetooth, sync data, guide setup and give users clear feedback, like the Airofit and CardiacSense apps we built.

Software as a Medical Device (SaMD)

Standalone software with a medical purpose, built under a documented lifecycle with requirements, risk controls and traceability from the first sprint.

IoMT and wearable platforms

Cloud platforms that ingest real-time vitals from wearables and connected devices, with secure device and user management.

Clinician dashboards and alerts

Live dashboards, thresholds and alerts that turn device data into something a care team can act on, supporting remote monitoring.

Data pipelines and analytics

Scalable pipelines that store, clean and analyse device data, with audit trails and role-based access.

EHR, lab and system integrations

HL7/FHIR and API connections to EHRs such as Epic, lab systems and the tools your business already runs.

Built Around IEC 62304 and ISO 14971

Regulated software is judged on process as much as on code. We build to the same lifecycle your quality team and auditors expect, and we work inside your quality system rather than around it.

IEC 62304 software lifecycle

Planning, requirements, architecture, implementation, verification, release and maintenance, with the software safety class set by your risk analysis. Our guide explains IEC 62304 for medical software.

ISO 14971 risk management

Hazard analysis and risk controls tied directly to requirements and tests, so every mitigation can be traced. See risk management in medical device development.

Traceability and verification

Requirements linked to design, code and test evidence, with verification and validation planned alongside development, not after it.

Security and privacy

ISO 27001-compliant security practices, secure cloud deployment, encryption, audit trails, and HIPAA and GDPR-ready data handling.

Regulatory ownership stays independent

Your quality and regulatory team, or an independent regulatory partner we work with, owns submissions and certification. That keeps the assessment unbiased. Learn what regulators count as Software as a Medical Device.

A clear development process

See how the phases fit together in our guide to medical device software development phases.

AI Features We Build for Device Data

Devices produce a steady stream of signals. AI turns that stream into something useful, built into the product from the start.

Illustration of a device signal chart with an anomaly highlighted

Signal analysis and anomaly detection

Models that read sensor and device signals, flag unusual patterns and cut noise before data reaches clinicians.

Illustration of a rising trend crossing a threshold with an alert bell

Predictive alerts and risk scoring

Trend-based alerts and risk scores that warn users and care teams early, with thresholds you can tune and review.

Illustration of device data condensed into a clinician summary

Clinician summaries and insights

Plain-language summaries of device data over time, so reviews take minutes instead of scrolling through raw readings.

AI that informs diagnosis or treatment can itself be regulated as SaMD. We scope that early, so the right level of validation and documentation is planned from the start.

Medical Device Software Development Cost and Timeline

Cost depends on the device, the software’s risk class, the integrations you need and how much regulated documentation the product requires. Most clients start with a focused companion app or MVP and expand.

Companion app MVP

From $25,000

Mobile app that pairs with your device, syncs data, shows live and historical readings and supports onboarding, with a cloud backend and a lightweight documented process. Typically 8–12 weeks.

SaMD-grade platform

Typically $60K–$150K

Full IEC 62304 lifecycle, ISO 14971 risk management, traceability, verification and validation, cybersecurity and a regulated release process.

Enterprise or multi-device platform

Typically $150K–$350K+

Multiple devices, markets and user types, with deeper integrations, AI features, analytics and enterprise-grade security.

These ranges cover software design, development and testing. Regulatory submissions, notified-body fees and quality-system certification are separate and handled by your regulatory team or a partner. Budget for cloud hosting and third-party services too. See our healthcare app development cost guide for how scope drives cost. Share your device and intended use and we will scope your build and price against it. You own the code, IP and data.

Why MedTech and Pharma Brands Choose Latent

Deep Domain Expertise

Trusted by global medical device manufacturers, pharma brands, and B2B health platforms across 14 countries.

Built for Compliance

IEC 62304 lifecycle, ISO 14971 risk management, ISO 27001-compliant security, and HIPAA and GDPR-ready software with audit trails.

Designed for Scalability

Modular systems that grow with your product—across use cases, markets, and devices.

Connected Ecosystem

From CRM to eCommerce, we integrate seamlessly with your tools, platforms, and APIs.

Fast, Focused Delivery

Get focused MVPs live in 8–12 weeks, guided by sprint-based execution and technical leadership.

Post-Launch Partnership

We don’t stop at delivery—ongoing support, upgrades, and roadmap development included.

Case Studies in Medical Device Software

Cardiac Sense – Wearable Device + Real-Time Monitoring

Built mobile app & cloud platform to sync health vitals from heart wearables. ✅ Boosted retention by 60% with real-time insights and alerts ✅ Enabled remote care through live dashboards and data streams

Airofit – Connected Respiratory Trainer

Developed a cross-platform mobile app for a respiratory device brand. ✅ Enhanced user experience and engagement for global customers ✅ Integrated training modules, progress tracking, and user feedback loops

Arthrex (Avana) – Medical Device eCommerce

Created an eCommerce platform tailored for doctors purchasing Arthrex devices. ✅ Improved conversions of doctors for surgeon labs and exhibits ✅ Built-in approval workflows for streamlined registrations