HAPPYneuron is proud to announce that its quality management system has just passed the ISO 13485 certification by Bureau Veritas Certification France for its ability to design, develop, sell and maintain Medical Devices for Cognitive Remediation and Rehabilitation and provide associated services.
This process enabled HAPPYneuron to register with the ANSM (the French National Agency of Security for Drugs and Health Products) its first class 1 medical device for cognitive remediation of patients suffering from multiple Sclerosis.
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2016, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard extends the requirements of the more general ISO 9001 standard in the context of this industry.
Franck Tarpin-Bernard, HAPPYneuron President, indicates that «this certification acknowledges the work done on our quality management system for all our processes. Being the first French company in the Digital Brain Health market to achieve this certification, we are showing our determination to reinforce our medical positioning and to be an example in this young and growing industry. This is an additional guarantee for all our industrial partners and health care customers.»
HAPPYneuron will now engage in obtaining the equivalent standards in North America to facilitate its development in the US and Canada. Other medical devices are also being registered at the same time.