Marta Montilla Gispert

Group IVDR Regulatory Affairs Manager at Unilabs

Speaker

With a Bachelor's degree in Biochemistry from UAB, Barcelona, I developed a solid understanding of the molecular principles underlying the in-vitro diagnostic (IVD) tests. I further advanced my expertise through postgraduate studies specializing in Quality Systems and Medical Device, completed both at UB in Barcelona, respectively.

With over 12 years of experience in the IVD field my career began with a focus on research, approached through from both scientific and Quality-by-Design (QbD) perspectives. This foundation led me to take on leadership roles in quality control, where I served as a batch releaser, gaining in-depth expertise in compliance, product evaluation, and release processes. Expanding my expertise into regulatory affairs, I have led the development and implementation of regulatory strategies, including Notified Body submissions from the manufacturer’s perspective. This has provided me with a comprehensive understanding of the product lifecycle.

At Unilabs I’ve played a key role in driving excellence through a global perspective on the implementation of the in-house tests within European and Swiss markets, including disciplines such IVD, pathology, genetics, and artificial intelligence disciplines.