Quality management for in-vitro diagnostics international

For setting up or monitoring a quality management system for medical devices, Metecon is your partner for preparing for audits and inspections, helps with the adaptation to modified requirements, checks manufacturing processes, and much more.

Test our skills – we look forward to your project!


Here's what you should know for your QM:

There are a number of programs and initiatives around the world that have made it their mission to harmonize the various QMS requirements. The Medical Device Single Audit Program (MDSAP), for example, is the effort of a working group of the International Medical Device Regulators Forum (IMDRF) (formerly GHTF - Global Harmonization Task Force) with the goal of harmonizing QMS requirements for manufacturers of IVD/medical devices. The following MDSAP countries are participating: Japan, Canada, Australia, USA and Brazil.

The advantages through mergers like the MDSAP (and many more) are obvious for you as a manufacturer: The goal of only one audit for recognition in several countries reduces the associated workload in the long run. Our team of experienced QM and IVD experts will help you find and implement the best options for your target markets.

Do you have questions about your QMS, are you wondering which mergers are right for you? We will be happy to find out together with you.
Arrange a meeting now - we look forward to working on a project together!

Our services in detail

  • Developing, managing, and maintaining quality management systems and quality management manuals including operating procedures and work instructions,
  • Analyzing and advancing quality scores relating to customers, suppliers, and production as well as preparing relevant reporting,
  • Introducing and implementing quality management (QM) tools,
  • Training and workshops on skills focusing on:
    • Quality regulations,
    • Statistical methodologies,
    • Frame contracts/quality agreements,
    • Complaint handling/CAPA (corrective action - preventive action),
    • Medical device vigilance/recall,
  • Suppliers for medical device manufacturers:
    • Supplier selection,
    • Supplier audits,
    • Supplier assessment.

Fit for today, fit for the future!

Our workshops give you the competence you need and help you master your current challenges. Let us find out together what you really need. Our expert workshops are always sustainable and individually tailored.

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