Medical Device Software
Medical Device Software Development & Compliance
Build Reliable Software for Certified Medical Devices
Medical electronics demand the highest standards of safety, performance, and compliance. Whether you’re building diagnostic equipment, patient monitoring systems, or wearable health trackers, your software must operate flawlessly — and comply with stringent regulatory frameworks.
At Promwad, we provide end-to-end embedded software development for medical devices, aligned with IEC 62304, ISO 13485, EU MDR, and FDA Class I/II requirements. Our experts guide you through the entire lifecycle: from planning and risk assessment to firmware development, testing, and documentation for regulatory submissions.
What We Offer
Embedded Software for Medical Electronics
- Real-time firmware for sensors, motor control, or imaging
- Medical communication protocols: HL7, DICOM, etc.
- Data acquisition and digital signal processing
- GUI/HMI development for touchscreens and wearable displays
- Wireless data sync with smartphones and cloud platforms
Compliance-Aligned Development Lifecycle
- IEC 62304 software safety classification (A, B, C)
- Risk management (ISO 14971) and traceability matrix creation
- Software documentation for EU MDR and FDA 510(k)
- Unit, integration, and system-level verification & validation (V&V)
- Cybersecurity planning for connected medical devices
Hardware & Platform Support
- Bare-metal MCU and RTOS-based devices (ARM Cortex-M)
- Embedded Linux on NXP i.MX, TI AM62x, and STM32MP1 SoCs
- Secure bootloaders, OTA update systems, and power management
- Interfaces: I2C, SPI, CAN, UART, USB, BLE, Wi-Fi, NFC
UX and Connectivity Integration
- Bluetooth health profiles, companion apps, and APIs
- Qt/QML or LVGL GUI for touchscreens
- Secure storage and encryption (AES, TLS, HIPAA-aligned)
- Battery life optimisation for portable and wearable devices
Supported Device Categories
Wearables & Trackers
ECG patches, temperature monitors
Diagnostic Instruments
Spirometers, ultrasound, analysers
Connected Therapeutics
Drug delivery systems, neurostimulators
Patient Monitoring Devices
Pulse oximeters, BP monitors
Mobile Medical Apps (SaMD)
Remote diagnostics, wellness dashboards
Our Development Workflow
Why Promwad
20 years of experience in embedded systems and certified software
Familiarity with ISO 13485, IEC 62304, ISO 14971, and GDPR/HIPAA
Engineering + compliance teams under one roof
Flexible cooperation: turnkey development or team extension
Expertise in both wearable consumer health and clinical-grade devices
Let’s Build Medical Devices That Perform and Comply
Let’s turn your infotainment vision into a scalable reality!
Drop us a line about your project! We will contact you today or the next business day. All submitted information will be kept confidential.