Regulatory & Market Access

Overview

We supported our MedTech clients with thousands of medical device and IVDs projects:

  • Building Technical file.
  • Leading the risk management activities.
  • Leading Design and Development process.
  • Registering their products globally.
  • Leading the certification process for CE mark, FDA approval and global market access.
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CE Mark (EU MDR 2017/745) & (EU IVDR 2017/746).

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US FDA 510(k) Consulting for Medical Devices and IVDs

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Medical Device and IVD Regulatory Affairs and quality

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Post Market Surveillance

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Quality Management and Training

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Biological Evaluation Report

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Global Registration consulting for Medical Devices and IVDs (Device Registration)