SyntheticMR receives their EU Medical Device Regulation (MDR) certificate
SyntheticMR announced today that they have received their EU Medical Device Regulation (MDR) certificate. This is a necessary step to continue to provide the European market with SyMRI 12.1 after May 2024. With this new certificate, SyntheticMR will also be able to release new products on the European market, which are significantly different from already existing products, such as SyMRI 3D.
The EU MDR regulate the worldwide production as well as the distribution of medical devices on the EU market. The MDR replaces MDD that was the former directive requirements for medical devices in the EU, with higher requirements on safety and performance. The MDR has existed since March 2017 and the QA/RA and R&D teams at SyntheticMR has since then, put a lot of work into implementing the new MDR regulations. "This has been one of my biggest goals and one of my top priorities during my four years at SyntheticMR. We have finally reached this goal" says Madeleine Enström, Quality Assurance and Regulatory Affairs Manager at SyntheticMR AB.
For additional information, please contact Ulrik Harrysson, CEO, SyntheticMR AB, +46 70 529 29 87 ulrik.harrysson@syntheticmr.com or Madeleine Enström, Quality Assurance and Regulatory Affairs Manager, +46 13 101 650 madeleine.enstrom@syntheticmr.com
SyntheticMR AB develops and markets innovative software solutions for Magnetic Resonance Imaging (MRI). SyntheticMR AB has developed SyMRI®, delivering multiple, adjustable contrast images and quantitative data from a single 5-minute scan. The SyMRI product is available in different packages. SyMRI NEURO delivers multiple contrast images, tissue segmentations and quantitative data on the brain. SyMRI MSK provides multiple contrast images and quantitative data for knee and spine anatomies. SyMRI NEURO is CE-marked and FDA 510(k) cleared and SyMRI MSK is CE-marked. SyMRI is a registered trademark in Europe and the USA. SyntheticMR is listed on the Spotlight Stock Market Exchange in Stockholm, Sweden. For more information, visit www.syntheticmr.com.
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