Aleah Care Vaginal Dilators Kit; Competence Enhancement MDR

Purpose and goal: ** Denna text är maskinöversatt **

The project aimed to build and strengthen internal competence with a focus on quality and regulatory eligibility requirements according to the MDR. The goal was to be able to start clinical evaluation and clinical trials and obtain a significant increase in competence internally. The work with the technical documentation was more extensive than expected. In summary, the project has contributed to significant competence enhancement and prepared us for future regulatory challenges.

Expected results and effects: ** Denna text är maskinöversatt **

With the help of external competence enhancement, we wanted to increase the focus on the clinical and regulatory work. We also wanted to strengthen internal competence through knowledgetransfer and prepare for clinical investigation. Within the project, we received clinical and regulatory advice for a greater understanding of which eligibility requirements we must meet, produced a clinical investigation synopsis, worked with risk analysis and decided to wait with BEP and the initial contact with Notified Body, since the production will move

Approach and implementation: ** Denna text är maskinöversatt ** Clinical and Regulatory Strategy Workshop for a common understanding of the clinical and regulatory requirements Statistical discussions, calculation of sample size and measurement method Preparation of clinical investigation synopsis

Systematic review of technical documentation through supervision Workshop for risk analysis Meetings and reconciliations through out the process Initiated investigation of potential factories in SV/EU who can meet the regulatory requirements before moving. Evaluation of the project.