• Quality Management System
    • QMS Implementation
    • Auditing
  • Technical documentation
    • Medical Devices Regulations
    • In-Vitro Diagnostic Devices Regulations
  • Market access
    • Start-ups
    • Medium sized companies
    • Established multinationals
    • Areas of the world
  • About BioTop Medical
    • History
    • Our Team
    • Jobs
    • Mission
    • Links
    • Let us help you with your documents

+31 (0)71 528 01 12

Contact us

Quality Managment System

  • QMS Implementation
  • Auditing

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

Services

Quality Management System for Medical Devices Companies

An essential step for bringing medical devices into the market, whether in the EU or in North America, is the implementation of a Quality Management System by the legal manufacturer. This is not only necessary but required to ensure that the processes needed are in place to guarantee that the product or services are delivered in a controlled and consistent manner and in compliance with the regulatory requirements.

BioTop Medical can assist you with a range of customer-tailored services to develop and implement a Quality Management System (QMS) in an efficient and cost-effective way and to maintain it in compliance. Over the years BioTop Medical has implemented QMSs in numerous medical devices companies working in the different medical devices’ segments i.e. development, production, sales, and distribution.

At BioTop Medical, we aim at the following objectives, for a successful implementation:

  • Adapt to each new company situation;
  • Understand and adhere to the company culture;
  • Explain the requirements to those in the company who must apply them;
  • Integrate the standard requirements in the company culture and natural processes;
  • Improve our clients’ company effectiveness with a minimum increase of “paper–work”.
Get in touch

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

Quality Managment System

  • QMS Implementation
  • Auditing

Technical Documentation

  • Medical Devices Regulations
    • Risk management
    • Clinical evaluation
    • Biological Safety Asessment
    • Other
  • In-Vitro Diagnostic Devices Regulations
    • Risk management
    • Performance 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
  • Quality Management System
    • QMS Implementation
    • Auditing
  • Technical documentation
    • Medical Devices Regulations
    • In-Vitro Diagnostic Devices Regulations
  • Market access
    • Start-ups
    • Medium sized companies
    • Established multinationals
    • Areas of the world
  • About BioTop Medical
    • History
    • Our Team
    • Jobs
    • Mission
    • Links
    • Let us help you with your documents

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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