With the Neola system, Lund-based Neola Medical wants to offer neonatal care a tool to better monitor the lungs of premature babies. The system makes it possible to monitor the status of the lungs continuously, which enables early detection of complications. The hope is that this will lead to more children surviving and living a life without serious disabilities as well as freeing up important time for the healthcare staff.
Advancing towards market application
Neola Medical is currently in the final phase of development. Recently reporting its third quarter, the company announced that the large investigator-initiated clinical study at the University Hospital in Cork, Ireland, had been completed, showing good results. Some of the important activities going forward will be technical verification studies and clinical validation studies. These will form the basis for the market applications to be submitted to the authorities in the EU and the US. Read more about the report here.
Certified according to ISO 13485
A prerequisite for selling the system is the CE mark and the company are now one step closer to a CE marking. Neola Medical announced earlier this week that the company’s quality management system had been certified according to ISO 13485. ISO 13485 is a standard where certification means that the company complies with laws and meets requirements for security, traceability, reporting to authorities and requirements from customers.
The certification was conducted by the certification body BSI Group The Netherlands B.V. and, according to Neola Medical, showed that the company ”has a well-reviewed and comprehensive quality management system for the development, manufacture, sale and fulfillment of regulatory market requirements of medical devices.”
Comments from the CEO
BioStock contacted Neola Medical’s CEO Hanna Sjöström to find out more about what the ISO certification means for the company.
First of all, what does it mean that you are now certified according to ISO 13485?
– A certified quality management system is a prerequisite for us to be able to sell medical devices internationally, and this means that we now have another foundation stone in place in our commercialisation plan.
You describe this as an important step towards obtaining CE marking. What other steps need to be taken?
– We now continue to work intensively with the planning and implementation of our technical and clinical studies to achieve both CE marking and FDA approval. In parallel, we are preparing for market launch with a focus on the US market. We are especially targeting the US because it is a country where many babies are born prematurely and where neonatal intensive care is being expanded.
