The EU-funded REALM project proposes to build a platform for the robust and uniform evaluation and certification of such healthcare software. The platform will integrate global regulatory guidelines and legislation alongside methodologies for effectively implementing real-world data. It will assist in the assessment of medical/healthcare software, ensuring that the necessary quality standards are met. Five software projects generated through the REALM ecosystem will be implemented in three European countries, and the consortium will use artificial intelligence technologies to support technology assessment and regulatory decision making.