Regulatory roadmap & Clinical Development Plan for Intelligyn: AI-driven diagnostic support of ovarian tumours

Purpose and goal:

The goal of the project was to initiate the regulatory process by establishing a technical files of the product IntelligynAI, initiate a quality documentation system, contact with notified bodies (NB), dreft plan for clinical studies and train Intelligyn´s staff. We feel that all goals have been met and that we now have a clear understanding of the process and the additional steps needed to be able to push InytelligynAI through the regulatory process.

Expected results and effects:

We have designed a series of documents that describe the product and its use and development in a clinical context (Intelligyn Target Product Profile, Intelligyn product Development Plan) quality documentation and control (Document handling and record control), description of the three regulatory user studies (Usability and Safety, Feasibility and Clinical Benefit) which will be the basis for MDR proposal.We have carried out a training of the staff which increased knowledge and understanding of the MDR process and quality management of the product´s development.

Approach and implementation:

We have had regular meetings with Prevas. Right from the start, we created a common area in Google drive where we shared all documents. We have worked with the documents together and discussed their content and design at the joint meetings. In this way, we have gradually learned about the process and requirements for IntelligynAI. In addition to this, we have completed a final training to support the team in working further towards an MDR proposal.