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 that enable you to focus on creating innovative products to 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
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