• Quality Management System
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+31 (0)71 528 01 12

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Market access

  • Start-ups
  • Medium sized companies
  • Established multinationals
  • Areas of the world
    • Europe
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For direct contact call
+31 (0)71 528 01 12

Services

USA: Market Approval

Depending on the classification of the medical device you would like to export to the USA, either a 510(k) or Pre – Market Approval (PMA) by the Food and Drugs Administration (FDA) will be required. The product classification method applied by the FDA differs significantly from the one used in the EU. It is crucial to know at an early stage of the project how your product is classified in the USA because this will have an enormous impact on the strategy for market approval. The compliance and the resources requirements for a 510(k) or a PMA route are considerably different. BioTop Medical can assist you to dertermine the classification of the device, the selection of the applicable standards and guidelines as well as with setting up the necessary documentation to be submitted to the FDA for each path.

An important aspect of the whole process is good communication. BioTop Medical has extensive experience in communication with all stakeholders in the development and production of medical devices, including the FDA reviewers. Clear-cut, simple and precise wording is used to ensure that the necessary details are shared in a practical and appropriate fashion preventing unwanted delays on the critical path to market approval.

Get in touch

BioTop Medical

  • Poortgebouw Noord
  • Rijnsburgerweg 10
  • 2333 AA Leiden, The Netherlands
  • T:+31 (0)71 528 01 12
  • F:+31 (0)71 528 10 15
  • info@biotopmedical.nl

Quality Managment System

  • QMS Implementation
  • Auditing

Technical Documentation

  • Medical Devices Regulations
    • Risk management
    • Clinical evaluation
    • Biological Safety Asessment
    • Other
  • In-Vitro Diagnostic Devices Regulations
    • Risk management
    • Performance evaluation
    • Other

Let us help with your documents

  • We conduct literature searches
  • We collect and assess clinical datasets and write clinical evaluation reports (CERs)
  • We lead and oversee the risk management process
  • We write the biological safety assessment report
  • We prepare your technical documentation
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Contact us
  • Quality Management System
    • QMS Implementation
    • Auditing
  • Technical documentation
    • Medical Devices Regulations
    • In-Vitro Diagnostic Devices Regulations
  • Market access
    • Start-ups
    • Medium sized companies
    • Established multinationals
    • Areas of the world
  • About BioTop Medical
    • History
    • Our Team
    • Jobs
    • Mission
    • Links
    • Let us help you with your documents

BioTop Medical

  • Poortgebouw Noord
  • Rijnsburgerweg 10
  • 2333 AA Leiden, The Netherlands
  • T:+31 (0)71 528 01 12
  • F:+31 (0)71 528 10 15
  • info@biotopmedical.nl

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