Medical Device Regulatory Services

Navigate medical device regulations seamlessly with Zedkey Global Connect’s Regulatory Services. From compliance to market access, trust our expertise for efficient solutions tailored to your needs.

Regulatory affairs support that goes beyond submissions

Zedkeyglobalconnect has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product(s) to market. Our risk-balanced approach and strategic direction contribute to positive business impacts and set your organization up for greater success.

DCGI Dossier

Our regulatory consultants for the Drug Controller General of India (DCGI) are equipped to generate and furnish various essential documents required for DCGI submissions. Our comprehensive DCGI dossier includes the following key documents:

  • IFU and Labels
  • Manufacturing Process Flow Chart
  • Design and Development Summary
  • Essential Principle Checklist
  • Device Master File
  • Risk Management Report
  • Clinical Evaluation
  • Animal Study
  • Biological Evaluation

CE Dossier​

Our regulatory consultants for the CE are equipped to generate and furnish various essential documents required for CE submissions. Our comprehensive CE dossier includes the following key documents:

  • Accreditations
  • Technical Comparison
  • Packaging Description
  • MSDS
  • Sites of suppliers & subcontractors
  • Technical Specifications
  • Assembly Drawing
  • Lables
  • IFU and Implant Card
  • DD Summary
  • List of Standards
  • Manufacturing Process and QC Summary
  • General Safety and Performance Requirement
  • Risk Management
  • Bench Test
  • Biological Evaluation
  • Sterilization Validation
  • Stability Study
  • Animal Study(If applicable)
  • Clinical Evaluation
  • Medicinal Substance (If applicable)
  • Post Market Surveillance
  • Declaration of Conformity
  • EUR Agreement & EAR Certificate
  • Summary of Safety and Clinical Performance
  • Person Responsible Regulatory Compliance
  • Technical Documentation

Design History File​

The Design History File encompasses a series of five key phases:

  • Design Input
  • Design Output
  • Design Process
  • Design Verification
  • Design Validation
  • Design Transfer

ROW Dossier

This dossier will be prepared according to country-specific requirements.

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