# Frequently asked questions > Answers about akranIQ's services, regulated software practice and ways of working. Source: https://akraniq.com/faq/ Publisher: akranIQ (https://akraniq.com) ## About akranIQ ### What does akranIQ do? akranIQ makes hardware smart. We engineer the software that lets devices, machines and equipment sense, connect, decide and act, covering firmware, connectivity, cloud platforms, apps and edge AI, from chip to cloud. ### What is intelligent engineering? Intelligent engineering is building products where software runs the hardware: sensors capture data, firmware and connectivity move it, AI decides on the device or in the cloud, and updates keep improving the product after it ships. ### Which industries does akranIQ serve? Healthcare and medical devices, industrial automation, smart buildings and energy, robotics and mobility, consumer and wearable devices, and logistics and asset tracking. ### Does akranIQ work on regulated products? Yes. We follow an IEC 62304 software lifecycle with ISO 14971 risk management and produce documentation aligned with FDA 21 CFR 820, EU MDR and CDSCO MDR 2017 expectations for medical device software. ### How can we work with akranIQ? As a fixed-scope project, a dedicated team or a team extension. You can start small with a proof of concept and scale up. Use the contact form to describe your device and timeline. ## Embedded Healthcare Services ### 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. ## Embedded Engineering & IT/OT ### What embedded engineering expertise does akranIQ offer? Firmware and RTOS development, board bring-up, wireless connectivity (BLE, Wi-Fi, LoRaWAN, cellular), secure boot and OTA updates, device apps and cloud back ends, delivered by one team. ### Which services are included? Product strategy, hardware and software design, IoT platform build, IT/OT integration, edge AI, verification and validation, and post-release support. ### How does IT/OT transformation improve operations? Joining device and plant data to enterprise systems gives you live visibility, remote diagnostics and predictive maintenance, and reduces manual reporting and downtime. ### What are the business benefits? Shorter time to market, fewer integration surprises, audit-ready documentation and a single accountable team from chip to cloud. ## Software Product Engineering ### How does software product engineering reduce cost and time to market? One team owns strategy, build, test and release, so there are fewer hand-offs, earlier integration and less rework. Automation in the build and test pipeline shortens every cycle. ### How do you design and launch a new product? We start with discovery and architecture, build in small tested increments, and plan the release, support and regulatory documentation alongside the code. ### Is it safe to use AI in a regulated product? Yes, with controls. We validate models, keep decisions explainable, put humans in the loop where required and monitor performance after release, all documented for your quality system. ### How do you engage with us? As a fixed-scope project, a dedicated team or an extension of your existing team. We can start small with a proof of concept. --- To start a conversation, use the contact form: https://akraniq.com/contact/