Medical and Pharma Regulatory Services

Medical and Pharma Regulatory Services Medical and Pharma Regulatory Services Medical and Pharma Regulatory Services
  • Homepage
  • Europe MDR Technical Doc
  • Labeling Services
  • QUALITY MANAGEMENT SYSTEM
  • Full MDR Class I Package
  • About Us
  • FDA U.S. Agent Services
  • More
    • Homepage
    • Europe MDR Technical Doc
    • Labeling Services
    • QUALITY MANAGEMENT SYSTEM
    • Full MDR Class I Package
    • About Us
    • FDA U.S. Agent Services

Medical and Pharma Regulatory Services

Medical and Pharma Regulatory Services Medical and Pharma Regulatory Services Medical and Pharma Regulatory Services
  • Homepage
  • Europe MDR Technical Doc
  • Labeling Services
  • QUALITY MANAGEMENT SYSTEM
  • Full MDR Class I Package
  • About Us
  • FDA U.S. Agent Services

The Full mdr package for class I medical devices

Compliance at an Affordable Price

This FULL COMPLIANCE package is designed for small Medical Device Companies. 


It includes everything needed to meet European MDR requirements for Class I Medical Devices. 

  1. Authorized Representation in Europe, with a 12-Month Contract
  2. Authorized Representative Mandate
  3. Registration in Eudamed
  4. Two Updated Labels for the Technical File Report
  5. Technical Documentation Report
  6. Clinical Evaluation Report
  7. Postmarket and Surveillance Report
  8. Declaration of Conformity
  9. Quality Procedures for the Systems Listed Above

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  • Homepage
  • Europe MDR Technical Doc
  • Labeling Services
  • QUALITY MANAGEMENT SYSTEM
  • About Us

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