• 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

About us

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

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

Services

About BioTop Medical

Since 1997, BioTop Medical provides services related to quality management system and regulatory affairs to medical device companies, thus supporting them bringing their products to the European and North American markets.

Our objective is to establish customised strategies to achieve and maintain regulatory compliance in a flexible, efficient and effective manner.

We support our clients with the development and implementation of tailored processes required to bring their products to the market, and by providing them with hands-on management of Regulatory Affairs and Quality Assurance activities.

BioTop Medical builds long-term relationships with its clients ensuring in depth product and process knowledge.

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

We (barely) use cookies

We only use essential cookies on our website. We don't use tracking cookies. You can decide wether you want to allow cookies or not.

Ok Only use functional cookies