Medical Devices

Create a more efficient, high performance business with product development, marketing and regulatory compliance services.

Digital Services

Overview

Create a more efficient, high performance business with end-to-end product development, marketing, and regulatory compliance services.  Atos Syntel enables you to focus on developing innovative products that create healthier, more empowered patients across the globe.

We also offer next-generation digital offerings like IoT, Big Data and analytics to help transform your enterprise, connect with customers, and put the power of data to work for you.

Offerings

Device Engineering

  • Concept & Idea Generation
  • Design & Development
  • Verification, Validation and Reliability
  • Lifecycle Support
  • End-of-Life Support
  • Quality Assurance & Regulatory Affairs Support
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EU MDR/ IVDR Compliance

  • 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 
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Labeling and Packaging

  • Label Consulting, System Implementation and Validation
  • Package Design and Development
  • Artwork Creation and Change Management
  • Quality Control, Proofing and Validation
  • Digital Transformation and Automation
  • Sterile Packaging Services
  • SPL Conversion Services
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PMS and PV

  • Automated Pharmacovigilance Case Processing 
  • Adverse Event & Complaint Management
  • Safety Data Management, Analytics, and Risk Management
  • Consumer Complaint Support
  • Social Media Integration 
  • Electronic Medical Device Reporting
  • Safety Surveillance and Reporting
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Digital Services

  • Big Data & Analytics
  • Internet of Things (IoT)
  • Real World Evidence
Learn More
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HubSpot - https://forms.hubspot.com/uploads/form/v2/3969078/bbe48aa3-2423-445f-8dbf-6c60ff818834 Pardot - http://connect.syntelinc.com/l/5412/2014-04-28/w7mlk

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