EU MDR / IVDR Compliance

Making an effective transition to EU MDR/IVDR

Digital Services

Overview

The long-anticipated May 2020 deadline for EU MDR compliance is fast approaching, and many medical device and diagnostic companies are struggling with this complex, risky and difficult transition.

With a global team of medical device experts, Atos|Syntel has more than a decade of experience delivering digital transformation solutions across the value chain for leading global clients.

As a pioneer in EU MDR/ IVDR solutions, Atos|Syntel blends onsite leadership consultants, a talented offshore delivery team, and technology, regulatory and process expertise to deliver large-scale compliance programs across the device segment.

The Atos|Syntel Advantage

Atos|Syntel has more than a decade of experience meeting quality, regulatory and compliance needs, and helping transform business processes to meet industry standards and regulatory guidelines.

  • Right Skills/Capabilities: Experienced team of Medical Device professionals with strong training in EU MDR and other domain skills.
  • Quality Assurance: Stringent QA process to adhere to your quality standards and regulatory compliance needs.
  • Regulatory Knowledge: Experience with FDA, EU MDR, ISO, GxP guidelines and medical device standards.
  • Innovation Focus: Accelerators and frameworks to support continuous improvement and process efficiency.
  • Flexible Operations: Support for a variety of operations, delivery models and pricing strategies.
  • Scalability: The size, scale and training capacity to ramp-up a team in 2-3 weeks.
  • Cost Savings: Blended onsite/offshore delivery model at highly competitive rates.

Success Stories

EU MDR labeling gap assessment for a Fortune 500 healthcare services company

When a Fortune 500 pharmaceutical and medical device distribution company acquired a medical device business, they needed to quickly re-brand the products while ensuring EU MDR compliance.

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Post Marketing Surveillance and Periodic Safety Update Reporting for a pharmaceutical and medical device company

A multinational specialty pharmaceutical and medical device company needed help managing the implementation of Post Marketing Surveillance (PMS) systems across five different business units (lens care, ophthalmic, surgical, aesthetics and pharma devices) in order to meet EU MDR requirements before the May 2020 deadline.

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Helping a Global Medical Device and Pharmaceutical Company Comply with EU Regulations

The client is a top 5 medical device, pharmaceutical and consumer packaged goods manufacturer with approximately $70 billion in annual revenue.

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