Célia Cruz
Célia Cruz is Chief Regulatory Affairs Officer at Complear Health. Célia is Co-Chair of the TOPRA Special Interest Network (SPIN) for Software as a Medical Device (SaMD) and Digital Health.
JournalMD5: The evolution of the EU Medical Device Regulation
This is a report of the MD5 session that took place at this year’s Symposium.
JournalMD3/IVD3: A global snapshot – Non-EU regulatory updates for medical devices and IVDs
This is a report of the MD3/IVD3 session that took place at this year’s Symposium.
JournalImplications of the EU’s AI Act for medical devices and in vitro diagnostic medical devices
The integration of artificial intelligence within healthcare has heralded a new era of innovation for medical devices and in vitro diagnostics. This article explores some implications of the EU’s AI Act for the existing regulatory frameworks governing MDs, specifically the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.