Medical Devices and Healthcare

Medical Standards and Quality Certifications

• ISO 13485:2016 – Quality Management System for Medical Devices

• Risk Management based on ISO 14971 and IEC 62304 guidelines

• Regulatory Compliance – FDA, 21 CFR, EUMDR, RoHS, IEC 60601

• Alliance Partnerships with Microsoft, Intel and IoT Global Network

• Partnerships with premier academic institutions, prototype and electronic manufacturers, external consultants

• ISO 9001:2015 – Quality Management System

• ISO 27001:2013 – Information Security Management System

• ISO/IEC 20000-1 – Information Technology Service Management System

• Appraised at CMMI Dev Version 1.3 Level 5

Success Stories

• Designed and developed an end-to-end cloud-based remote patient monitoring portal for monitoring 27 vital signs of the patient in a location where medical support is not available.

• Designed a compact portable Point-of-Care device and fulfilled the client required cost optimization, reusability and reduced development time.

• Reengineering of a secure connected clinical disinfection system with innovative features such as self-diagnostics and automated system health check.

• IoT-based design of a smart clinical bin with load sensors, RFID, bar code readers and camera for tracking the disposed items and sending alerts to hospital system.

• Threat modeling and threat analytics of a connected ambulatory Drug Infusion System.

• Concept to design of a sensor-based compact Continuous Glucose Monitoring System that is cost-effective and easy to use.

K.V. Krishnan, Ph.D.

Practice Head – Medical Devices
and Analytical Instruments Solutions

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