Medical Device & Pharma

Companies in the Medical Device & Pharma industries are under significant pressure to successfully expand on new opportunities while navigating highly complex regulatory requirements. We help clients deliver through this shifting landscape by advancing their digital thread capabilities.

Industry Expertise

Regulatory & Quality

Regulatory support and ability to transform to regulations changes, submissions and deliver with Quality.

Clinical Technology

Insight-driven approach with an integrated Product record and reusable structured building blocks for clinical reporting.

Medical Technology

Intelligence and automation solution approach by leveraging proven, modern technology.

Capabilities

We offer a full range of services in Strategic Consulting and Technology to the Medical Device and Pharma Industries that help clients deliver better outcomes and enable process reorchestrations across the Product lifecycle.
Digital Regulatory & Integrated Product Record

Build an intelligent and connected enterprise that enables better and faster product submissions to meet regulations and enable faster distribution.

  • Regulatory Information Management process
  • Integrated UDI process and submission engine
  • Shipping controls based on regulatory approvals
  • Integrated Product with IFUs/eIFUs, DHF/DMR information
  • Harmonized Design & Doc control with CAPA, Non-Conformance (NC), Complaints and Audits traceability
  • End to end Product Lifecycle Management
Data Analytics & Systems Engineering

Enable a data-oriented organization for better traceability and informed decisions.

  • Data Exploration and Analysis
  • Data intelligence by leveraging Machine Learning (ML)
  • Data Migration
  • Cloud/Enterprise Application Integration
Cloud for Medical Devices

Scale business solutions to achieve the full potential of a cloud-based architecture.

  • Business case for cloud-based strategy
  • On-Prem to cloud migrations

Take the Next Step

Connect with us to learn more about our process and services. Together, we can determine which services align best with your objectives.

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