Instituto Pedro Nunes, through its Medical Devices Regulatory — support unit team, in collaboration with NOVA Clinical Research Unit (NOVA CRU) organized the event “Marketing Your Medical Device: A Comprehensive Journey Through Regulatory Compliance and Clinical Evaluation” in Lisbon. This event provided a unique opportunity for participants to connect with TÜV SÜD Italy’s leading MDR and IVDR auditors and deepen their knowledge of the regulatory landscape.
We had a panel of experts in the field of medical devices and in vitro diagnostics such as
– Ana Brito (MDRu) presented the steps to CE marking
– Carlo Gherardi (TUV SUD Italy) covered pre-clinical testing
– Sandra Balseiro (MDRu) gave insights into clinical and performance evaluation
– Lúcia Domingues and Catarina Silvério (NOVA-CRU) spoke about clinical investigations and safety for medical devices
– Francesca Bevilacqua (TUV SUD Italy) discussed the process of reference laboratories for IVDs
– Agnese Mengoli (TUV SUD Italy) covered the submission process for notified bodies
– Célia Ludovino, Mariana E. Reis, and José Leovigildo Coelho spoke about the success cases of BHL-Medical, Indústria de Produtos Hospitalares, Lda, C-mo Medical Solutions and IONIC Health respectively.
Special thanks to Stefano Bolletta Bolle from TUV SUD and Rita Rocha from NOVA-CRU.
This event highlighted the importance of regulatory compliance and clinical evaluation for the success of medical devices and in vitro diagnostics. We are committed to continuing to promote events that drive knowledge and innovation in healthcare.