corpuls3 is MDR certified
GS Elektromedizinische Geräte G. Stemple GmbH (also known under the brand name “corpuls”) has received MDR certification for its corpuls3 and corpuls3T defibrillators. The medical technology company's devices, which can be divided into three modules, meet the very stringent requirements of the EU Medical Device Regulation (MDR). Thus, making corpuls a leading provider of a future-proof, MDR certified telemedicine solution.
“This success once again confirms that corpuls not only stands for innovation, but is also the epitome of high-quality medical technology,” says Christian Podolak, Vice President of Quality Management, Design Assurance & Regulatory Affairs. With the certificates issued by TÜV SÜD Product Service GmbH in accordance with the Medical Devices Regulation 2017/745/EU, the corpuls3 meets the requirements of the highest risk class III for medical devices. The regulation, which came into force in 2021, is intended to ensure even greater safety, quality and transparency for medical devices in the EU. “The text regarding the law alone is now three times longer than it was - that shows how much more regulated it is now,” says Podolak. "We therefore see the certification not only as confirmation, but rather as an incentive to continuously develop our high standards of quality."
Complete MDR certified telemedicine solution
The telemedicine software corpuls.mission LIVE and the chest compression device corpuls cpr have already overcome the MDR hurdles. Now that both corpuls.mission LIVE and corpuls3 are MDR certified, the company is automatically strengthening its telemedicine platform corpuls.mission. “The current certification brings a further boost to our telemedicine solution, which is already in demand worldwide,” says CEO Dr. Christian Klimmer. corpuls devices are in use in 75 countries worldwide and our telemedicine solutions are already in use in 30 countries - major projects are underway in Norway as well as in New South Wales, Australia and Hong Kong. In Germany, corpuls.mission is used in several states as part of their Tele-emergency projects.