• 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

Auditing

Auditing your own quality management system is necessary to identify problems or potential problems, and to prevent quality and compliance issues. Auditing the quality systems of your critical suppliers is a way to actively control their reliability, and therefore, the constant compliance of your product. Regulatory changes often lead to the necessity of updating the quality system. QMS updates are best performed when they are planned. The first step is to perform a systematic gap analysis. The second step consists of implementing the required changes and finally, the internal audit is the method to verify the effectivity of the implementation. BioTop Medical offers all these services; from the gap analysis to the audit.

Auditing requires extensive resources including an “experienced eye” to identify non-conformities and potential nonconformities.

BioTop Medical offers to its clients:

  • Experienced auditors;
  • Independent assessment;
  • Complete and clear audit reports;
  • Advice on possible improvement actions;
  • Planning of the follow-up actions.
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
  • BioTop Medical © 2023
  • Website by Secure Design
  • 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

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