Software in a Medical Device (SiMD)
Firmware and control software for monitors, pumps, wearables and diagnostic equipment.
Medical Device Software Development Services
Safe, connected software for the next generation of medical devices
akranIQ helps MedTech companies and device makers build the software their products depend on: embedded firmware, patient and clinician apps, connected cloud platforms and AI-driven diagnostics. We engineer to IEC 62304 and keep the documentation your regulators expect.
Wearable to app to cloudLive ECG over BLE · signed firmware updates
20+years of device, IoT and solution architecture experience
IEC 62304software lifecycle followed from day one, with ISO 14971 risk management
1 teamfor firmware, apps, cloud and QA, so nothing falls between vendors
FDA · EU MDR · CDSCOregulatory pathways our documentation and security practice are built for
Why healthcare companies partner with akranIQ
Medical software has to work on the hardware, in the hospital and in front of the regulator. akranIQ brings device engineering, connectivity and regulated software practice into one team, so nothing falls between vendors.
- Firmware, apps and cloud built by one team that understands the device
- Development aligned to IEC 62304 and ISO 14971 from day one
- Security and privacy designed in for FDA, EU MDR and HIPAA
- Interoperability with EHR, EMR and imaging systems via HL7, FHIR and DICOM
- Cost-effective engineering from India with flexible engagement models
Medical devices and embedded software solutions
From firmware inside a bedside monitor to an AI model reading scans in the cloud, we deliver the software layers a modern medical product needs.
Software as a Medical Device (SaMD)
Standalone diagnostic, monitoring and therapy apps for patients and clinicians, on mobile, desktop and web.
AI-enabled SaMD
Machine-learning models for signal and image analysis, validated, explainable and monitored after release.
Connected devices and IoMT
Secure device-to-cloud connectivity with fleet dashboards, remote diagnostics and over-the-air updates.
Digital health platforms
Remote patient monitoring and care platforms that link devices, patients and care teams.
Health data and diagnostics
Data pipelines, analytics and clinical dashboards built on device and EHR data.
Embedded Medical Device Software
We build the software that runs on and around your medical hardware. That includes the firmware on the device, the patient-facing mobile app that pairs with it, and the clinician-facing desktop and cloud tools used to review data and make treatment decisions.
Everything connects: to the device over BLE, USB or Wi-Fi, to the hospital through HL7 and FHIR, and to your support team through secure remote diagnostics.
Firmware and RTOSDrivers, sensors and real-time control on MCUs
Device control appsWindows, macOS, Android and iOS
Secure firmware updatesSigned OTA with rollback and recovery
Reset and service toolsFactory reset, calibration, field service
Remote diagnosticsLive logs and audited remote sessions
Device securityDevice identity, encryption, anti-tamper
Engineered for regulated markets
We work inside your quality system and deliver the software records your design history file needs.
IEC 62304ISO 14971IEC 62366-1IEC 81001-5-1FDA 21 CFR 820EU MDRCDSCO MDR 2017HIPAAGDPRHL7 / FHIR
Work models that fit your project
Start small with a proof of concept, or bring us in as your full medical software team.
Fixed-scope project
A defined deliverable, such as a device control app or an OTA update system, at an agreed price and timeline.
Dedicated team
An akranIQ team of embedded, app, cloud and QA engineers working as your product team over the long term.
Team extension
Specialist engineers who join your existing team to add firmware, connectivity or AI skills.
Medical device software: your questions, answered
What is medical device software development?
It is the engineering of software that is part of, or is itself, a medical device: firmware on monitors, pumps and wearables, patient and clinician apps, and cloud platforms. It follows a controlled lifecycle such as IEC 62304 with risk management under ISO 14971.
What is the difference between SiMD and SaMD?
Software in a Medical Device (SiMD) runs inside a physical device, for example firmware in a patient monitor. Software as a Medical Device (SaMD) is standalone software that performs a medical purpose without being part of hardware, for example a diagnostic app.
Does akranIQ follow IEC 62304 and ISO 14971?
Yes. Development is aligned to IEC 62304 and ISO 14971 from day one, with traceability from requirements through risk controls to verification, and the records your design history file needs.
Can you build AI-enabled medical software?
Yes. We build machine-learning models for signal and image analysis that are validated, explainable and monitored after release, and we document them for your quality system and regulatory submissions.
How do you handle security and privacy for health data?
Security and privacy are designed in for FDA, EU MDR and HIPAA expectations: device identity, encryption, signed firmware updates, audit logging and data minimisation, with interoperability via HL7, FHIR and DICOM.
Which regulations and standards are supported?
IEC 62304, ISO 14971, IEC 62366-1, IEC 81001-5-1, FDA 21 CFR 820, EU MDR, CDSCO MDR 2017, HIPAA, GDPR and HL7 / FHIR.
Looking for custom medical device software for your business?
We tailor our work model to your product, timeline and regulatory path.