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  • Home
  • Our Services
    • ISO Certifications
      • ISO 14001 EMS
      • ISO 9001 QMS
      • ISO 50001 Energy
      • ISO 17025 Labs
      • ISO 22716 GMP Cosmetics
      • ISO 45001 OHSMS
      • ISO 13485 Medical Devices
      • ISO 21001 Education
      • ISO 15189 Labs
      • ISO 27001 Information Security
      • ISO 22000 / HACCP / FSSC
    • Other Certifications
      • Halal Certification
      • UKCA & UKRP
      • Organic Certification
      • Carbon Footprint Verification
      • EU-REP & EUDAMED
      • SA 8000 Social Accountability
      • CE Marking
      • FDA cGMP / 510(k)
    • Regulatory Affairs (Medical Devices & Other Industries)
      • IVDR (EU 2017/746)
      • Labelling & IFU Compliance
      • MDR (EU 2017/745) Documentation
      • PMS / PMCF
      • Technical File
      • Product Testing Guidance
      • Risk Management ISO 14971
      • UDI & GSPR
      • Biocompatibility ISO 10993
      • Cleaning, Sterilization, Packaging Validation
      • Clinical Evaluation (CER)
    • Importer & Representative Services
      • US Agent (FDA)
      • EU Representative
      • UK Representative (UKRP)
      • Green-List Eligibility (Import Alert 76-01)
      • FDA Facility Registration
      • FDA Device Listing
      • EUDAMED Registration
    • Documentation Development
      • ISO Trainings
      • ISO Manuals
      • SOPs
      • Forms
      • Process Maps
      • Company Profiles
      • Product Catalogues
      • HR & Admin Policies
      • Production, QC & Dispatch SOPs
    • Audit Services
      • Mock Audit for Certification
      • Supplier Audits (2nd Party)
      • Pre-Assessment Audits
      • FDA cGMP Audits
    • Training & Capacity Building
      • Production / QC Training
      • Auditor Trainings
      • Regulatory Affairs Training
      • Compliance Training
      • Food Safety Trainings
      • Documentation Development Training
    • Special Consulting Services
      • KPI Development
      • Business Setup & Compliance
      • Company Policy Design
      • Quality Plans
      • Tender Documentation
      • CAPA & RCA
    • CSR (Corporate Social Responsibility) Services
      • Environmental
        • Carbon Footprint Standards
        • ESG Reporting
        • Waste Management SOPs
        • Energy Saving Audits
        • Eco-Label Support
      • Social
        • Worker Safety SOPs
        • Ethical Trade Compliance
        • Anti–Child Labour Audits
      • Governance
        • Workplace Policy Development
        • Internal Audits
        • Compliance Training
  • Export Compliance Services
    • Labeling & Packaging Guidance
    • Export Documentation
    • HS Code Selection
    • Product Testing Requirements
    • Country-Specific Requirements
  • Industry
    • Medical Devices
    • Chemical & Industrial
    • Food Industry
    • Construction / Contracting / Scaffolding
    • Beauty & Cosmetics
    • Surgical Instruments
    • Sportswear / Leather / Textile
    • E-commerce sellers
  • Contact us

IVDR (EU 2017/746)

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