• 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
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  • About us
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+31 (0)71 528 01 12

Contact us

About us

  • History
  • Our mission
  • What we offer
  • Links
  • Jobs

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

About BioTop Medical

Our Mission

Our mission is to guide companies in bringing and maintaining their medical devices on the market. Our work is primarily focused on the EU, but we also have experience for the USA, Canadian and Brazilian markets. Building long term relationships with our customers and understanding their products, challenges and difficulties is our unique selling point.

BioTop Medical stands for honesty, integrity and knowledge. We believe in the need for regulations. While we understand the restrictions legal manufacturers feel, we also see the opportunities that they can create.

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
  • BioTop Medical © 2025
  • Website by Secure Design
  • Please read our disclaimer
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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