In a new interview with Direkt Studios, CEO Hanna Sjöström talks about the company’s preparation for market launch, including both the regulatory focus and an increased clinical presence. See the interview below (in Swedish).
Neola Medical is in an exciting phase as the company is in the finalizing stage in the development of Neola®, the company’s medical device for continuous lung monitoring of preterm born infants. The company now enters a phase with regulatory focus, but also studies for technical verification and clinical validation moving forward. This is extensive work that lays the foundation for upcoming applications for market approval in the EU and the U.S. In a new interview in Direkt Studios, CEO Hanna Sjöström talks more about the company’s work approaching market launch. For instance, she talks more about the certification of the company’s quality management system according to ISO 13485 and the importance of such certification.
In the interview Hanna also talks more about the company’s recruitment of a Clinical Manager and the stronger clinical focus. In the interview she talks more about the company’s work to widen the company’s clinical network through more extensive clinical presence with visits to neonatal intensive care units and participating at conferences.
See the interview here (in Swedish).