EU MDR / IVDR Compliance

Easing the Transition to EU MDR / IVDR

Digital Services

Overview

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, Syntel is helping medical device companies seamlessly transition to new European Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulations (IVDR).

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.

Offerings

  • 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 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
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