CE-Marking - Competence enhancement with the help of regulatory expertise regarding IVDR

Purpose and goal

To secure the regulatory expertise within the True Dose team to navigate the IVDR landscape, achieve CE marking and ensure successful launch.

Expected effects and result

•Fully approved Technical and QMS documentation. •Approval for CE marking of the TD kit for the first 6 cancer drugs. •Training materials and workshops conducted in QMS and regulatory eligibility requirements. •Protocol from competence transfer and identified key people within TD who are responsible for regulatory issues going forward. •A clear plan for how the competence will be maintained within the company after the end of the project (CEO and development manager (super user) will be trained.

Planned approach and implementation

Peter Löwendahl leads the following activities for the True Dose team: o Conduct initial gap analysis: Identify existing skills gaps in regulatory eligibility requirements and QMS. o Design and conduct customized training and workshops: Train the True Dose team in IVDR, risk management and relevant standards. o Supervise implementation of QMS o Review and approve documentation o Conduct practical exercises and case studies