Embedded Software Development for Medical Device Compliance and Performance Optimization

The client faces difficulties in rapidly bringing new medical devices to market while ensuring compliance with strict healthcare standards and regulations. They need to develop embedded software that supports advanced features such as secure communication, telemetry, and predictive maintenance, all within a highly regulated environment that demands reliability, security, and timely performance.

A rapidly expanding medical device manufacturer specializing in emergency and diagnostic equipment seeking to accelerate product development, ensure regulatory compliance, and enhance device reliability.

• Expand and accelerate embedded software development capabilities to meet increasing product demand.
• Ensure the software complies with relevant healthcare standards and regulations, including industry-specific security and telemetry requirements.
• Improve device reliability and availability, targeting a zero-downtime operational expectation.
• Implement advanced features such as secure data transfer, firmware updates, predictive maintenance, and seamless connectivity (WiFi, Bluetooth).
• Reduce time-to-market for new device firmware releases through agile development and rapid scaling of engineering resources.

• Implementation of secure communication protocols with telemetry servers for patient data and device logs.
• Support for wireless connectivity (WiFi, Bluetooth) including connection management and stability.
• Functional operation for instant ECG printing via Bluetooth printers and exporting data to PDF/email/fax for remote consultation.
• Automated collection and upload of user session and device service logs for predictive maintenance.
• Firmware update mechanisms ensuring compliance with healthcare security and safety standards.
• Fast boot times, ensuring devices can deliver critical treatments within mandated timeframes.
• Multithreaded data processing with robust handling of concurrent operations.

• Telemetry servers for remote data transfer and device management
• Bluetooth printers for immediate ECG printing
• Email and fax systems for data forwarding to healthcare providers
• Healthcare regulatory compliance tools and libraries

• Full compliance with healthcare industry standards such as IEC 60601, EN 1789, and relevant directives
• Data security and privacy according to healthcare regulations
• Device reliability with 100% uptime expected
• Fast boot times within 10 seconds for critical emergency devices
• Scalability to support rapid deployment across multiple devices and locations

The project is expected to significantly enhance the client’s product portfolio by enabling faster time-to-market for medical devices, ensuring compliance with strict regulatory standards, and improving device reliability and operational efficiency. Anticipated outcomes include achieving 100% device uptime, streamlined compliance processes, and quicker response times for emergency medical scenarios, thereby strengthening market position and reducing costs associated with device failures and regulatory delays.