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    • ISO 13485 Quality Management System
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    • Medical Device Risk Management
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    • Clinical investigations
      • How is Clinical Research Conducted?
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      • For Which Devices Are Clinical Trials Mandatory?
      • Who is the Sponsor/Supporter in Clinical Trials?
      • Clinical Trial Duration?
      • Clinical Trial Costs?
      • Provision of Volunteer Patients?
      • Voluntary Patient Insurance Status?
      • Are clinical trials required for MDR transition for products that have been marketed with existing MDD documentation?
    • Post-Market Surveillance System (PMS)
      • PMS Report
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      • UDI consists of UDI-DI and UDI-PI
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Referencesadmin2024-12-04T03:31:05+03:00

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  • HOMEPAGE
  • CORPORATE
    • About Us
    • Our Quality Objectives
    • Our Quality Policy
    • References
  • OUR SERVICES
    • ISO 13485 Quality Management System
    • Installation of the appropriate infrastructure and guidance
    • 2017/745/EU Medical Device Regulation (MDR) Preparation of Technical File for CE Marking/Certification
    • Medical Device Risk Management
    • Process Validations
    • Clinical Evaluation
    • Post Market Surveillance (PMS)
    • Biological Evaluation
    • Usability
    • Software Validation
  • MDR
    • MDR Introduction
    • MDR Requirement
    • What Does MDR Bring?
    • Common Specifications
    • Clinical Trials
    • Post Market Surveillance System (PMS)
    • UDI Codes
    • Implant Card
    • European Database (EUDAMED) Registrations
    • European Representative / Authorized Representative
    • Person Responsible for Regulatory Compliance
    • Product Liability Insurance
  • Training
  • Contact Us
info@conformed.com.tr
+90 544 937 82 53
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