Newronika -Quality Management System - Brain Device
Newronika Quality Management System ensures proper implementation and effective monitoring of design, development, purchasing, production, marketing, customer communication, and assistance processes. The implementation and maintenance of the Quality Management System represents the way Newronika has worked since the company started. The application of the Quality Management System ensures that the products comply with regulatory and custom requirements.
The Products are designed and manufactured in accordance with the European Directive 93/42/EEC and 90/385 on medical devices and meet the requirements of harmonized standards that apply to them. Requirements set by Canadian MDR and South Korea are also comply with.
The certification of conformity to the ISO 13485 has been released by authorities in the EU, Canada, and South Korea.