As a leader for 20 years in the development of advanced devices and solutions for human movement therapy, Hocoma and Quo collaborated in the development and documentation of active medical devices. Quo was able to contribute with its in-depth knowledge of the relevant product standards such as IEC 60601-1, IEC 60601-1-2 and process standards such as ISO 13485, ISO 14971, IEC 62304.
Close on-site collaboration with Hocoma's product management and development teams allowed for the updating and redrafting of the respective documents. In addition, type testing activities in the field of electrical safety and Electromagnetic Compatibility (EMC) were guided and performed with the help of Quo.
“This unprecedented milestone allows us to secure continued market access to the European Union and other countries relying on the European system for medical device certification as a crucial element for our growth strategy.”
As a result, Hocoma was one of the first medical device companies in the rehabilitation robotics industry to successfully achieve compliance with the Medical Device Regulation (EU)2017/745.
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