• 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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+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

Medium-Sized-Companies

Your company has been operating successfully for several years and you effectively managed the quality and regulatory activities of the organization. However, the regulatory environment is changing, and the requirements continue to increase. Perhaps you need a partner to talk to, so you can find solutions to the difficulties you are facing. Maybe you need hands-on support to complete a project or an internal audit to challenge your system. Contact us with your needs. With our experience in quality and regulatory affairs, we would be happy to help you and your company.

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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