• Services
    • Quality Management System
      • QMS Implementation
      • Auditing
    • Technical Documentation File
      • Risk management
      • Clinical / Performance Evaluation
      • Systematic Literature Searches
      • Biological Evaluation
      • Other
    • Person Responsible for Regulatory Compliance
  • Our Clients
    • Who we work with
    • Start-ups
    • Medium sized companies
    • Large Companies
  • About us
    • History
    • Mission
    • What we offer
    • Links
    • Jobs

+31 (0)71 528 01 12

Contact us

Our clients

  • Who we work with
  • Start-ups
  • Medium sized companies
  • Large Companies

For direct contact call
+31 (0)71 528 01 12

Market access

Areas of the world

BioTop Medical helps medical device companies to bring their products to the European and North American markets. This is accomplished by establishing a robust strategy to achieve and maintain regulatory compliance. We support our clients in developing and implementing the required processes and provide hands-on, tailored management of the Regulatory Affairs and Quality Assurance activities. BioTop Medical builds long term relationships ensuring in depth product and process knowledge, which allows us to better assist our clients in achieving their goals.

Get in touch

BioTop Medical

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

Quality Managment System

  • QMS Implementation
  • Auditing

Technical Documentation

  • Risk management
  • Clinical / Performance Evaluation
  • Systematic Literature Searches
  • Biological 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
  • Services
    • Quality Management System
      • QMS Implementation
      • Auditing
    • Technical Documentation File
      • Risk management
      • Clinical / Performance Evaluation
      • Systematic Literature Searches
      • Biological Evaluation
      • Other
    • Person Responsible for Regulatory Compliance
  • Our Clients
    • Who we work with
    • Start-ups
    • Medium sized companies
    • Large Companies
  • About us
    • History
    • Mission
    • What we offer
    • Links
    • Jobs

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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