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    Complete Regulatory for Medical Device CE Marking, Technical File Preparation,
    Clinical Evaluation, EAR, FSC, Class I Compliant Certificate

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    US FDA Regulatory Service for Medical Device Registration,
    Device Listing, US Agent Service, 510k documentation and submission

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    Implementation Support for
    EN ISO 13485:2016, MDSAP, 21 CFR 820, 21 CFR 211, 21 CFR 111

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    GMP Consulting, GAP Analysis,
    FDA 483 Response and Closure for Medical Device, Drugs and Food Manufactures

About Us

  • EuropeCert is your regulatory compliance partner for Medical Device, Drug & Food according to rules and regulation of European Union and US Food & Drug Administration (FDA).
  • With our corporate office located next to Dusseldorf with its Medical and Pharma Industry Hub supported by offices in Chicago, USA and Bangalore, India.
  • Our services are always provided for a low fixed-fee, never by the hour and we work for the client till certification or clearances obtained.



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