Capacity Building: Compliance Strategy for Digital Dementia Screening

Purpose and goal:

The goal of this project is to begin establishing a regulatory strategy that includes developing a comprehensive plan for the approval and marketing of our medical device in the EU and other regions. We work with an external consultant with experience and specialization in regulatory compliance for medical devices and software. They will provide us with regulatory advice on product development, software risks and quality assurance throughout the project.

Expected results and effects:

After the project ends, we expect to have a proper regulatory documentation which will serve as the foundation for compliance, risk management, and operational efficiency. It is essential for maintaining trust with regulators, clients, and stakeholders, and ensures that Cognes Medical Solutions can adapt to changing regulations and market conditions. We expect to have an improvement in our current regulatory strategy and contributing to the company´s internal knowledge.

Approach and implementation:

Knowledge exchange is firstly done through the utilization of clinical and regulatory manuals tailored for the Cognes team. Secondly, through collaborative work with the Cognes team. Thirdly, through comprehensive training sessions conducted for selected members of the Cognes team. The Project Manager will be the initial recipient of knowledge transfer, actively involved in the entire process. The acquired knowledge will be disseminated to the broader Cognes team.