• Quality Management System
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    • In-Vitro Diagnostic Devices Regulations
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  • About BioTop Medical
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    • Let us help you with your documents

+31 (0)71 528 01 12

Contact us

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

Canada: Product Licensing

The legislation applied and the route to market approval in this country, is different from that in the EU and in the USA. Unlike the USA, the approach for device classification is similar to that in the EU, but the implications of the product class on documents required with the device licence application is different. BioTop Medical can assist you to determine the classification of the device, the selection of the applicable standards as well as with setting up the documents to be submitted to Health Canada.

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 Health Canada reviewers. Clear, 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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