# Embedded Healthcare Services: Medical Device Software Development

> Embedded firmware, patient and clinician apps, connected cloud platforms and AI-driven diagnostics for medical devices, engineered to IEC 62304.

Source: https://akraniq.com/healthcare-services/
Publisher: akranIQ (https://akraniq.com)


Safe, connected software for the next generation of medical devices. akranIQ helps MedTech companies and device makers build the software their products depend on, and keeps the documentation regulators expect.

## Medical devices and embedded software solutions

- **Software in a Medical Device (SiMD):** Firmware and control software for monitors, pumps, wearables and diagnostic equipment.
- **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

- **Firmware and RTOS:** Drivers, sensors and real-time control on MCUs
- **Device control apps:** Windows, macOS, Android and iOS
- **Secure firmware updates:** Signed OTA with rollback and recovery
- **Reset and service tools:** Factory reset, calibration, field service
- **Remote diagnostics:** Live logs and audited remote sessions
- **Device security:** Device identity, encryption, anti-tamper

## Engineered for regulated markets

Standards and regulations we work to: IEC 62304, ISO 14971, IEC 62366-1, IEC 81001-5-1, FDA 21 CFR 820, EU MDR, CDSCO MDR 2017, HIPAA, GDPR, HL7 / FHIR.

## Work models

- **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.

## Frequently asked questions

### 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.
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