Medical Device Development and Testing

Enabling Patient-centric Care with Smart Edge 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.

eInfochips 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, 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.

Why eInfochips for Medical Device Development and Testing?

Concept to manufacturing partner with first time right design, cost optimization focus

Enabled the world’s 1st AI-at-the-Edge ultrasound solution

Auto injectors for a billion $ pharma company

Strategic partnerships from device to digital for early access to technology, product roadmaps
In-depth expertise in optimizing and processing complex image and video algorithms at the edge
Strong compliance and regulatory process expertise – IEC 60601-1/2/6, IEC 62304, ISO 13485, 14971, FDA (21CFR), HIPAA
Award winning point-of-care telehealth solutions for remote patient diagnostics

Key Offerings

Product Engineering
Value analysis and Value engineering
Digital Engineering
Quality Engineering and Compliance

Success Stories

Accelerating potential every day

FDA Class II Telehealth Examination and Diagnosis Device

Case Study – eInfochips team helped the client with complete product design and development of remote examination device. Qualcomm® partnership…

Case Study

Healthcare Mobile Application Development and Cybersecurity Testing

Case Study – eInfochips performed a detailed hardware component analysis and helped in designing a Kintex UltraScale FPGA based data acquisition unit…

Case Study

AI Enabled Connected Healthcare

Azure-based connected health platform development including cloud IoT, AI enablement and mobile applications

Case Study

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Device Partnerships
Digital Partnerships
Quality Partnerships
Silicon Partnerships


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