The Healthcare and Medical devices industry is undergoing a revolutionary transformation in the way solutions and devices are being formulated and developed. Medical devices are becoming more connected than ever and remote patient monitoring with data analytics is becoming a norm.

It is imperative for the medical device companies to adopt a strategic approach to stay ahead of the innovation curve by leveraging technology advancements in multiple areas such as mobility, wireless, cloud, and analytics to drive innovation that addresses market needs and challenges of longer device development cycles, optimization of development processes, and high production costs.

At Infosys, we help our clients in designing customized devices, end-to-end product development, maintenance, manufacturing support, regulatory documentation, and product compliance and certifications.

We also help optimize R&D cost and improve supply chain efficiencies by leveraging new technologies and partner ecosystems. This is to bring innovative medical devices and Software as a Medical Device applications into the market with the objective of improving patient care while reducing the cost of care. Our ISO 13485 certified processes and Quality Management System ensures high-quality product development which enables our client to meet their regulatory needs and objectives. With our recent acquisition of product design and development firm, Kaleidoscope Innovation, we plan to redefine patient treatment and consumer health across the globe.

Content Acquisition and ingestion

Medical Device Hardware, Firmware

  • Design,Development/Re-engineering & PLM
Content Enrichment

Medical Device Software and Mobile Medical Application

  • Development & Re-engineering
Workflow and Editorial Systems

Verification and Validation

  • Design Verification, System Verification and Tools Validation
Content Acquisition and ingestion

Test Automation

  • Automation Framework
  • Development and Automation Scripting
Content Enrichment

Cloud Enablement

  • Re-engineering and Migration for Cloud enablement
Workflow and Editorial Systems

Connectivity and Interoperability

  • HL7 , Laboratory, Workflow management, IHE, LAW
Content Acquisition and ingestion

Product Lifecycle Management

  • PLM strategy & roadmap, PLM ackage evluation and implementation
Content Enrichment

Regulatory Compliance

  • Documentation, DHF creation and remediation, CAPA Pre-compliance testing
Workflow and Editorial Systems

Patient & Physician Apps & Portals

  • Interfacing with sensors, Personal Care and Wearable devices & apps

Key Differentiators

Medical Devices Lab

Infosys has focused investments in setting up Medical Devices labs to drive technology development and delivery excellence in key areas such as Rapid prototyping, Tear down, Embedded Electronics, Mobile Compatibility Validation, etc. We also set up dedicated Labs for our clients thereby enabling seamless extension of their R&D team.

Medical Device Solutions and Accelerators

In order to accelerate the development and verification of medical devices, we have built multiple solutions and frameworks such as:

  • Remote Monitoring Solution for Hospitals and ICUs
  • Personal Care Devices Integration Solution
  • Change Based Regression Framework for reducing cycle time
  • Mobile Compatibility Validation Framework
  • Mobile Test Automation solutions
  • Digital Health and Monitoring Solution

Medical Device Academy

Our Medical Device Knowledge Academy focuses on developing domain certifications and training material for continuous knowledge enhancement for talents working in medical device projects. We have developed these for Cardiac Rhythm Management, Neuromodulation, Audiology, Sleep Apnea, Radiology and other domain areas.

Value Proposition of Infosys Medical Device Offerings

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Reduce R&D cost – Infosys has solutions, accelerators, and frameworks across the life cycle of medical device development which help manufacturers achieve faster time to market with reduced R&D cost.

Compliance to regulations – ISO 13485 certified Quality Management System to meet the compliance requirements by regulatory authorities like FDA.

Low cost product development for emerging markets – Value analysis, value engineering solutions, partnerships, and alliances for developing and re-engineering devices for emerging markets.


Challenges & Solutions

Infosys provides end-to-end solutions and services including electrical, mechanical hardware, embedded firmware, software, verification, and compliance testing using accelerators, frameworks, and solutions. We have test automation frameworks, simulators, electrical and mechanical verification labs, partnerships with product certifications vendors, and ISO 13485 certified Quality Management System which help in reducing development and verification cost.

Infosys has ISO 13485 certified Quality Management System and processes which help clients meet process requirements for regulatory compliance. Our DHF remediation framework helps clients identify gaps in documentation that are required to meet regulatory submission guidelines and create/update the design history file as per requirement of regulatory authorities.

Infosys value analysis and value engineering framework along with various labs such as teardown lab, rapid prototyping lab, and embedded electronics lab along with alliances and partnerships enable clients to develop low-cost devices for emerging markets.