Instituto Pedro Nunes organises event on regulatory compliance and clinical evaluation of medical devices
General
RTD Laboratories
Clique aqui para a versão em português.
.jpg)
Instituto Pedro Nunes (IPN) organised the event "Marketing Your Medical Device: A Comprehensive Journey Through Regulatory Compliance and Clinical Evaluation", through its Medical Devices Regulatory Unit, in collaboration with NOVA Clinical Research Unit (NOVA-CRU). This event, which took place at the NOVA Medical School (NMS Research) in Lisbon, was an opportunity for participants to interact with TUV SUD's main MDR and IVDR auditors and deepen their knowledge of the regulatory landscape.
TUV SUD, a leading European notified body in the certification of CE-marked medical devices and in vitro diagnostic medical devices, was present with its experts, offering valuable insights into the rigorous certification and CE-Marking processes.
.jpg)
The event was attended by a panel of experts in the field of medical devices and in vitro diagnostics, namely, Ana Brito (IPN - MDRu) who presented the essential steps for CE marking; Carlo Gherardi (TUV SUD Italy), who discussed pre-clinical trials; Sandra Balseiro (IPN - MDRu) provided detailed information on clinical and performance evaluation; Lúcia Domingues and Catarina Silvério (NOVA-CRU) addressed clinical research and the safety of medical devices; Francesca Bevilacqua (TUV SUD Italy) explained the process of reference laboratories for IVDs; and Agnese Mengoli (TUV SUD Italy) spoke about the notified body submission process.
The event was aimed at professionals and companies interested in deepening their knowledge of regulatory compliance and clinical evaluation of medical devices and in vitro diagnostics. The crucial importance of regulatory compliance and clinical evaluation for the success and commercialisation of these devices was highlighted.
.jpg)
About Instituto Pedro Nunes (IPN):
IPN is a benchmark institution for promoting innovation and supporting technological development. Through its Medical Devices Regulatory Support-unit, it offers specialised services in the regulatory support of medical devices and in vitro diagnostics medical devices in the global markets, helping companies navigate the complex regulatory journey required for the fast and effective development and commercialisation of new technologies, ensuring regulatory compliance.
About NOVA Medical School (NMS):
NMS is an institution dedicated to education and research in health sciences. Through NOVA CRU, it supports companies in the clinical research phase, offering a wide range of services that guarantee the quality and compliance of clinical studies, including: design and planning of clinical research/performance studies, development of clinical research protocols, preparation and submission of clinical trials or studies to the competent authorities, monitoring and management of clinical trials, data analysis, technovigilance and development of specific software for Clinical Research.
About TÜV SÜD:
TÜV SÜD is a leading European notified body in the certification of CE-marked medical devices and in vitro diagnostic medical devices, recognised for its expertise and rigour in assessing product conformity.
Instituto Pedro Nunes (IPN) organised the event "Marketing Your Medical Device: A Comprehensive Journey Through Regulatory Compliance and Clinical Evaluation", through its Medical Devices Regulatory Unit, in collaboration with NOVA Clinical Research Unit (NOVA-CRU). This event, which took place at the NOVA Medical School (NMS Research) in Lisbon, was an opportunity for participants to interact with TUV SUD's main MDR and IVDR auditors and deepen their knowledge of the regulatory landscape.
TUV SUD, a leading European notified body in the certification of CE-marked medical devices and in vitro diagnostic medical devices, was present with its experts, offering valuable insights into the rigorous certification and CE-Marking processes.
The event was attended by a panel of experts in the field of medical devices and in vitro diagnostics, namely, Ana Brito (IPN - MDRu) who presented the essential steps for CE marking; Carlo Gherardi (TUV SUD Italy), who discussed pre-clinical trials; Sandra Balseiro (IPN - MDRu) provided detailed information on clinical and performance evaluation; Lúcia Domingues and Catarina Silvério (NOVA-CRU) addressed clinical research and the safety of medical devices; Francesca Bevilacqua (TUV SUD Italy) explained the process of reference laboratories for IVDs; and Agnese Mengoli (TUV SUD Italy) spoke about the notified body submission process.
The event was aimed at professionals and companies interested in deepening their knowledge of regulatory compliance and clinical evaluation of medical devices and in vitro diagnostics. The crucial importance of regulatory compliance and clinical evaluation for the success and commercialisation of these devices was highlighted.
About Instituto Pedro Nunes (IPN):
IPN is a benchmark institution for promoting innovation and supporting technological development. Through its Medical Devices Regulatory Support-unit, it offers specialised services in the regulatory support of medical devices and in vitro diagnostics medical devices in the global markets, helping companies navigate the complex regulatory journey required for the fast and effective development and commercialisation of new technologies, ensuring regulatory compliance.
About NOVA Medical School (NMS):
NMS is an institution dedicated to education and research in health sciences. Through NOVA CRU, it supports companies in the clinical research phase, offering a wide range of services that guarantee the quality and compliance of clinical studies, including: design and planning of clinical research/performance studies, development of clinical research protocols, preparation and submission of clinical trials or studies to the competent authorities, monitoring and management of clinical trials, data analysis, technovigilance and development of specific software for Clinical Research.
About TÜV SÜD:
TÜV SÜD is a leading European notified body in the certification of CE-marked medical devices and in vitro diagnostic medical devices, recognised for its expertise and rigour in assessing product conformity.
