Purpose and goal
The project´s aim is to strengthen Neurawave´s regulatory competence for CE marking of the medical device Relief aHead for migraine treatment. By engaging external expertise, an independent preliminary review of the quality management system and technical documentation is carried out prior to submission to a notified body. The goal is review-ready documentation according to the MDR, lasting internal regulatory competence and a company equipped for market introduction.
Expected effects and result
The expected outcome is a quality-assured technical documentation and a quality management system ready for review by a notified body, as well as a prioritized action list for submission. The project builds lasting regulatory expertise internally. In the long term, this will enable CE marking and market introduction of a drug-free treatment that can improve the quality of life of migraine patients and reduce the need for drugs.
Planned approach and implementation
The project is carried out as an external, independent preliminary review of the company´s quality management system and technical documentation. The work begins with a structural review against the MDR, followed by assessment of content quality and cross-reference integrity and an internal audit according to ISO 13485. The review results in a prioritized action list. Through close cooperation between the external expert and the project team, a structured transfer of skills takes place
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The project description has been provided by the project members themselves and the text has not been looked at by our editors.
