After two years of complex product testing and in-depth audits, the Luxembourg-based medical tech company ExoAtlet obtained CE marking for its exoskeletons last August, opening up the door to the European market.
“Achieving the CE marking certification was an extremely time-consuming and resource-intensive process. But it was definitely worth it. The CE marking didn’t only grant us access to the European market; it also had a positive impact on our organization as a whole. Over the past two years, we have made important improvements to our products, our innovation processes, and even the way we work as a team. We have implemented the method of peer instruction, when senior employees educate juniors; while seniors have been going through constant training on the medical and high-tech side of rehabilitation with exoskeletons. As a result, the quality and user-friendliness of our exoskeleton have highly increased throughout the CE marking process,” – says CEO Ekaterina Bereziy.
As part of the certification process, the ExoAtlet exoskeleton was subject to a series of tests designed to confirm the load capacity, durability, and safety of the device. The exoskeleton was overloaded, pinched with heavy steel fingers, dropped to the ground, and tested for fire resistance and magnetic integration. Due to its complexity, the testing protocol had to be carried out by a specially accredited laboratory in South Korea. And to the relief of the ExoAtlet development team, each test was successfully passed by their beloved ‘creature’.
As CEO Bereziy admits, obtaining CE marking involved many unexpected challenges along the way. One of them was the requirement for the company to produce a complicated “doll” in order to carry out tests, such as evaluating the maximum load capacity of the various functions. Creating this “test dummy” wasn’t as straight forward as it sounds because it had to be created according to an extensive list of specifications. Surprisingly, it turns out that this dummy is a very useful thing to have which the company is now able to use for its own tests. “We now use this doll to check things like running time, uses with maximum load, and so on. It was a great idea and something we hadn’t thought of previously,” – note the ExoAtlet’s engineers.
ExoAtlet at the 2020 Cybathlon (Cyber Olympics)
Adding to the complexity of the CE marking journey, in ExoAtlet’s case, wasn’t just the product, but also the manufacturing process that was subject to certification. As mentioned earlier, ExoAtlet manufactures its exoskeletons in South Korea. Eventually, the manufacturer was granted the ISO-13485 certificate, a huge milestone on ExoAtlet’s road to CE marking. This is one of the many examples of how European certification has improved the quality of the ExoAtlet development processes.
Now that the CE marking has been obtained, what’s next for ExoAtlet? One of the priorities is to evaluate the user-friendliness of the upgraded ExoAtlet exoskeleton, based on the feedback from patients and medical practitioners in Europe. “We are excited to start our full expansion in the European area. In the near future, tests will be carried out in one of the leading German hospitals in the field of rehabilitation in Berlin. In parallel, negotiations are underway with clinics in the Benelux countries, France, Italy, and Portugal,” – states CEO Ekaterina Bereziy.
ExoAtlet specializes in the development of medical exoskeletons—wearable devices designed to help people with locomotor disabilities walk again. Since the company’s launch in 2015, over 6000 patients have benefited from rehabilitation treatment using an ExoAtlet exoskeleton. “When using our exoskeleton, patients are able to use their leg muscles again, which improves blood circulation. As a result, their overall physical health improves, and they are feeling better mentally too,” – explains Ekaterina Bereziy, founder and CEO at ExoAtlet. ExoAtlet’s exoskeletons are being used in over 70 medical facilities across China, Portugal, Russia, South Korea, Turkey, and Vietnam. In each of these countries, ExoAtlet successfully achieved the required product quality certifications.
To learn more about ExoAtlet and discuss partnership and collaboration opportunities in research, physical therapy education, and rehabilitation, you can contact Julia Vas at firstname.lastname@example.org and visit ExoAtlet’s website.