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
  • 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

Success Stories

Accelerating potential every day

FDA Class II Telehealth Examination and Diagnosis Device

Case Study

Healthcare Mobile Application Development and Cybersecurity Testing

Case Study

AI Enabled Connected Healthcare

Case Study

Featured Insights

Powering you ahead

Deep Learning & Computer Vision based Medicine Inventory Monitoring

Case Study

How connected medical devices could make healthcare services more efficient and effective

Blog

Augmented Reality – The Future of Medical Surgery

Blog

mHealth Apps – Transforming Healthcare Outcomes for Patients and Practitioners

Blog

Key Considerations in Selecting the Right Medical Device Design Partner

Blog

Web & Mobile App for Smart Healthcare Services

Case Study

Client Testimonial

eInfochips review by Andre Hendarman, Director of Silicon Technology Engineering, Teradyne

“In the ASIC product, the most difficult part is to manage the balance between time, quality, and cost. eInfochips has been our preferred partner for functional verification and helped us to balance between those three constraints. We rely on eInfochips for the familiarity of our design and the domain knowledge.”

Our other Industries

Pharma and Life Sciences

Digital Health

Talk To   Our Experts

eInfochips, an Arrow Electronics company, is a leading provider of digital transformation and product engineering services. eInfochips accelerates time to market for its customers with its expertise in IoT, AI/ML, security, sensors, silicon, wireless, cloud, and power. eInfochips has been recognized as a leader in Engineering R&D services by many top analysts and industry bodies, including Gartner, Zinnov, ISG, IDC, NASSCOM and others.

Headquarters
– USA, San Jose
– INDIA, Ahmedabad

Write to Us: marketing@eInfochips.com

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