Sooma is proud to announce that it has received certification that it conforms to the new stringent requirements of the EU Medical Device Regulation (MDR) by the Finnish notified body, SGS Fimko. This achievement marks the first instance of a transcranial direct current stimulation (tDCS) device manufacturer receiving this milestone certification and stands as a commitment to Sooma’s dedication to patient safety and product quality.
Introduced in 2017, the new regulation replaces and expands upon the EU Medical Device Directive of 1993 to increase oversight, traceability, post-market surveillance, and clinical evidence requirements for devices throughout Europe’s common market. This regulation provides authorities, healthcare professionals, and the public with easy access to information about medical devices, including the clinical evidence that supports their safety and efficacy, certification status, and adverse event reports, aiming to enhance transparency and improve the traceability of the devices throughout their lifecycle.
With less than 200 MDR certifications listed in EUDAMED, Sooma now joins a select group of industry leaders capable of meeting this new standard, which allows it to provide users with innovations and continue to improve its products to meet the market’s ever-changing needs.
“As the culmination of a multi-year effort, this is an achievement for our team in service of our patients throughout Europe,” says Tuomas Neuvonen, Sooma CEO. “We are proud of this milestone and even more excited for what it means for our future plans in treating psychiatric and neurological disorders, as only MDR-certified companies can release new products or major updates to existing products.”
Since its founding, Sooma has collaborated closely with renowned psychiatry and neurophysiology experts to develop effective treatment solutions for various conditions. Ten years later, Sooma’s portable neuromodulation devices are the most prescribed tDCS therapies worldwide having treated thousands of patients suffering from major depression disorder and chronic pain. Sooma’s commitment to facilitating patient access to care, improving treatment outcomes, and offering a cost-effective, scalable solution are the driving forces behind its cutting-edge treatments and leading quality devices.
Founded in 2013, Sooma is a Finnish medical device company specializing in non-invasive brain stimulation devices for neurological and psychiatric disorders. Sooma works closely with leading medical experts to develop effective treatment solutions. Manufactured in Finland, Sooma’s devices adhere to strict ISO 13485 and MDSAP quality management standards.
TDCS is the treatment method offered by Sooma for depression (Sooma Depression Therapy, indicated for Major Depressive Disorder) and chronic pain (Sooma Pain Therapy, indicated for Fibromyalgia and chronic neuropathic pain). By using Sooma devices, you ensure that you are performing a safe and effective patient treatment, should it be in the hospital or at patients’ homes, with legal, regulated, tested, and effective equipment that complies with the latest EU regulations and features all the recommended elements listed on this article.
Do you want to hear more about Sooma Depression or Pain Therapies? Our dedicated team will answer any questions you may have, and if you wish to proceed, they will help you get started with Sooma Therapy at your clinic or hospital!