Medical Devices
The healthcare industry has been responding extraordinarily during these challenging times and medical devices are playing a key role in powering data led healthcare decisions and delivering a better patient experience.
Archana Automation has hands-on experience in engineering FDA Class 2 and Class 3 medical devices for monitoring, diagnostics & imaging, wearable health and telemedicine. We provide HIPAA compliant medical product engineering services and have the required process expertise in IEC 60601-1/2/6, IEC 62304, 510K and ISO 13485.
We act as the innovation partner for many medical equipment and pharmaceutical companies, including Fortune 500 firms. Our engagements span across concept to prototype development, cross-functional validation, sustenance, value engineering and certification support.
Medical Devices Key Featuring
Product Engineering
- Electronics, mechanical, HW, SW, FW, BSP and OS porting
- High-speed, Multi-processor and FPGA board design
- Low power, portable designs with diverse communication interfaces e.g. BLE, RFID, Wi-Fi
Value analysis and Value engineering
- BoM optimization – cost (new market entry), components (EOL, obsolescence)
- Form factor optimization for miniaturization
- Feature enhancements (interfacing, connectivity)
Digital Engineering
- Connected Health / IoT platform development and consulting
- Improve diagnostics and prognostics accuracy with AI/ML at the edge and cloud
- Web, mobility, cloud applications – business intelligence, data analytics
- IoT cybersecurity from device to connectivity to cloud
- Data annotation for image, video and text data for ML algorithm training
Quality Engineering and Compliance
- End to end system testing- hardware, firmware, connectivity, and software
- Test automation framework for web, mobile applications
- Cross-functional system validation for compliance testing, documentation support