EU MDR / IVDR Compliance

Easing the Transition to EU MDR / IVDR

Digital Services


Complying with global regulatory regimes is expensive and cumbersome, with stringent new regulations rolled out every year. With a global team of quality, regulatory, functional, technical and therapeutic consultants, Atos Syntel helps medical device companies seamlessly transition to new European Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulations (IVDR).

Atos Syntel has the skills, infrastructure and experience to help you implement the new EU MDR regulations across your entire value chain. We are ready to support you with end-to-end program management including initial gap assessment, risk management, change management, resource management, quality and governance.


  • Consulting and Gap Assessment
  • QMS Implementation, ISO 13485:2016 Upgrade
  • Technical File Updates, Records Management
  • Clinical Evaluation Process Upgrades 
  • Unique Device Identifier (UDI) Implementation and Compliance 
  • Labeling and Packaging Updates
  • Device Re-Verification & Re-Validation
  • Computer System Validation (CSV)
  • PMS & Vigilance Consulting 
  • Digital Modernization & IT Support



The Atos Syntel Advantage

  • Diverse Therapeutic Experience: Experience working with large global clients in therapeutic areas including surgery, cardiovascular, orthopedics, ophthalmology, endocrinology, gastroenterology, nephrology and oncology
  • Domain Capabilities: Strong experience supporting Clinical Evaluations, Quality Assurance, Regulatory, Labeling, Packaging, Technical Documentations and Records Management
  • EU Regulatory Expertise- Up-to-date knowledge on EU MDR and IVDR changes, as well as  collaboration with notified bodies, QA & RA consultants and therapeutic experts

Success Stories

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

The regulations companies have to comply with are increasing and could pose temporary challenges for businesses. Assessing the impact of the regulations on business is therefore important as altered policies may require the organizations to change in the way they do business.

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Upgrading the Ophthalmic Product Manufacturer’s Quality Management Systems for EU MDR

The global regulatory environment is going through a continuous change with regulations governing significant businesses are regularly altered. Companies are at risk of losing the majority of their business if they do not comply with the changed regulations.

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