The In-Vitro Diagnostic Regulation (IVDR) is now here! What does it mean for the industry? How can companies ensure compliance after the 26th of May? In this episode of Transformation Talks, our in-house expert Ainoa Forteza, Associate Director of Regulatory Affairs, will discuss these and many other questions with Kenny Carberry, host of Transformation Talks and Director of Clinical Development at Alira Health.

Meet our speakers:

Ainoa Forteza - Associate Director of Regulatory Affairs, Alira Health

Ainoa Forteza is a Regulatory expert on Medical Devices and In Vitro Diagnostics. She helps companies develop their MedTech products according to the applicable regulatory requirements, with a special mention to MDR and IVDR. With 7+ years of experience in industry, Ainoa’s previous roles include positions at consulting firm (DDR, currently Veristat) where she was in charge of the team responsible for Medical Devices and In Vitro Diagnostics.

Meet our host:

Kenny Carberry – Director, Clinical Development, Alira Health

Kenny leads business development efforts and initiatives for early-stage healthcare companies. His background covers various indications across pharma, medical devices, and digital health. In addition to his expertise in business development, Kenny has several years of experience in clinical trial operations and management. He offers a unique perspective on the clinical development lifecycle, from generating a comprehensive strategy to executing a successful trial.