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  • Home
  • About Us
    • About Requalite
    • Our Values
    • Our Team
  • Services
    • Regulatory Consulting
    • Quality Management Consulting
    • Performance Evaluation Report
    • Clinical Evaluation Report
    • Literature Search Report
    • Post-market Surveillance Report
    • Periodic Safety Update Report (PSUR)
    • EU Authorised Representative (EC REP)
    • Gap Analysis
    • Training
  • Resources
    • EU Regulation 2017/746 (IVDR)
    • EU Regulation 2017/745 (MDR)
    • ISO 13485 QMS for Medical Devices
    • ISO 14971 Risk Management
    • White papers
    • Presentations
  • Links
    • Guidelines
    • Regulations
  • News
  • FAQ
  • Contact
  • en English
    en Englishde German

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Requalite GmbH
Jahnplatz 4, 82166 Gräfelfing

 

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☎  +(49)-89-328 00 304

✉    info@requalite.com

 

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Requalite is a medical device Regulatory and Quality Consulting company located at the heart of Europe, in Munich-Germany. We provide full technical and medical writing support to manufacturers of Medical Device and In vitro Diagnostic devices to obtain CE-marking as per EU regulations of MDR (2017/745) and IVDR (2017/746) for entering European market.

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