• 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
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  • About us
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+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

Our clients

Startups

You are a young dynamic company, and you are proudly developing a unique device. As a startup your resources are restricted and as one of the founders, you ‘wear several hats’, of which quality and regulatory are among them. Perhaps you have no or limited understanding of the regulatory environment of medical devices and you need help to get started. You will likely need help to overcome specific obstacles and require some coaching along the way. BioTop Medical understands your challenges as we have helped many startups before. Contact us to find out what we can do for you but don’t wait too long. Building the necessary documentation needed to support your device and eventually reach the market starts right at the beginning, in the design and development phase.

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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  • 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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