We Get Your Business Ready For 
European Medical Device Regulation (MDR)

SD MECHATRONIK WE HELP YOUR BUSINESS TO GET MDR CERTIFIED 

SD Mechatronik helps getting your products ready for the European regulation of medical devices (MDR). We provide evidence of how well your medical devices perform. We do structural tests, perform studies during development phase and required for PMS/PMCF, Quality Control. We help with the development and quality control of medical devices. Our key activities are:
  • Testing in accordance with ISO 20795, 19736, 14801, 14569, 11609, 10477, 7491, 6872
  • Abrasion resistance and breaking strength
  • Solubility and water absorption
  • Consulting, design and performance of client-specific tests
  • Tech support for students working on their Master’s theses or dissertations

Implementation of the EU Medical Device Regulation (MDR)

We offer you the following services to help you implement the MDR:
  • Studies during the development phase
  • Studies required for PMS/PMCF as set out in the MDR
  • Quality control of current production
  • Performance comparisons with competing products

Tests for Industrial Clients

For our industrial clients, we test structural elements and components using special procedures:
  • Fatigue strength/dynamic mechanical analyses
  • Lifespan of contacts, latches, closures etc.
  • Combined procedures such as multi-axis mechanical and electrical testing
  • Non-destructive testing with x-ray microtomography
  • 3D comparisons, reverse engineering, STL data generation of inaccessible components
  • Residual dirt analysis, technical cleanliness in accordance with VDA-19 and adherence of residual oil
  • Optical measurement of surface roughness
  • Microtensile tests to determine contact forces, latching forces etc.
  • Thermal shock, thermal load change, climate chamber 
"We use several test devices simultaneously to make sure you get safe, reliable results as quickly as possible."
– Sebastian Duy, Managing Director
CONTACT US NOW!
Do you have any questions about performing tests or test equipment? Or would you like to know more about our  services? Please contact us now! We're here to help.
CONTACT NOW

HOW YOU BENEFIT

We offer companies a service encompassing the performance of
various tests. Draw on our experience and resources to get results in the shortest possible time without investing in machinery!
  • No investment, operating and maintenance costs
  • High availability of the devices and quick reaction to your request
  • High level of expertise and excellent understanding of the devices

CONTACT SD MECHATRONIK

Do you have any questions about testing or test equipment? Would you like to know more about our services? If so, don’t hesitate – contact us now. We will be glad to help. Just fill out the form. We will get in touch with you very soon. You are also welcome to call us.