Medical Device Software

Medical Device Software Compliance in Development

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.

It is important to distinguish between standalone software intended for medical purposes and software embedded in a hardware medical device; standalone software operates independently of a hardware device, while embedded software is integral to the hardware device itself. The medtech industry is rapidly evolving, with regulatory frameworks and innovation shaping how medical device manufacturers and medical device companies approach compliance, cybersecurity, and product development.

What We Offer

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.

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 system (A, B, C) for risk-based categorisation
Risk management (ISO 14971) and traceability matrix creation to address associated risks
Software documentation for EU MDR and FDA 510(k)
Unit, integration, and system-level verification & validation (V&V)
Cybersecurity planning for connected medical devices, including input from external stakeholders
Implementation of software maintenance processes as required by IEC 62304
Adherence to quality system regulation and quality management systems (e.g., ISO 13485) for process traceability and compliance
Involvement of software developers in compliance, risk assessment, and development methodologies
Use of the classification system to determine the level of rigor needed during development
Ongoing assessment and mitigation of associated risks throughout the software lifecycle
Clear definition of the intended purpose of the software for regulatory compliance and approval
Consideration of performance requirements and their impact on regulatory submissions and device modifications

Compliance-Aligned Development Lifecycle

Compliance considerations for integrating off the shelf software components
Clinical evaluation to demonstrate software safety and performance
Engagement with external stakeholders such as providers, regulatory bodies, and industry partners in cybersecurity and compliance
Following FDA guidance and proposed regulatory framework for AI/ML-based devices
Alignment with standards set by international organisations such as ISO
Compliance with Health Canada and other regulatory agencies for global market access
Regulation of in vitro diagnostic device and vitro diagnostic device software under EU IVDR and other frameworks
Application of health software standards (e.g., IEC 81001-5) for cybersecurity and data protection
Monitoring future trends and their impact on medical device software standards
Integration of artificial intelligence and machine learning in medical device development and regulatory compliance
Ensuring safe and effective software and effective software through structured processes
Fulfilling the responsibilities of medical device manufacturers and medical device company obligations in compliance and best practices
Understanding the regulatory implications of software intended for medical purposes
Applying best practices in medical device development processes

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

1.Project Planning & Classification

2.Soft Architecture & Risk Analysis

3.Code Development & Testing

4.Verification, Validation, and Documentation

5.Regulatory & Submission
Support

Why Promwad

We don’t just write software — we design for compliance and longevity.

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

The Medical Device Software Development Process

Developing medical device software is a highly structured process designed to ensure that every product is safe, effective, and compliant with regulatory requirements. The software development process typically begins with thorough planning, where requirements are defined and a roadmap is established. This is followed by detailed design, careful implementation, testing, and ongoing maintenance.

Risk Management in Medical Device Software

Risk management is a cornerstone of medical device software development, ensuring that potential hazards are systematically identified, assessed, and controlled throughout the product lifecycle. Medical device companies must establish a comprehensive risk management process that includes hazard analysis, risk assessment, and the implementation of effective risk controls.

Cybersecurity in Medical Devices

As medical devices become increasingly connected and reliant on software, cybersecurity has become a critical concern in the medical device industry. Medical device companies must address the unique risks associated with software as a medical device (SaMD) and other connected health technologies to safeguard patient safety and data integrity.

Medical Device Software
Testing

Thorough testing is a vital component of the medical device software development process, ensuring that device software meets all design specifications, regulatory requirements, and performance standards. Medical device companies must develop and execute a comprehensive testing strategy that includes unit testing, integration testing, and system-level testing.

Let’s Build Medical Devices That Perform and Comply

Whether you're prototyping a new connected health device or optimising firmware for a certified product line, Promwad helps you meet performance, quality, and regulatory expectations.

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.