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Neola Medical receives ISO certification

Neola Medical has been ISO certified

Neola Medical receives ISO certification

22 November, 2022

Neola Medical is working hard towards the goal of obtaining market approval in the US with Neola, the company’s product for monitoring the lungs of premature babies. The company have now announced that the quality management system has been certified according to ISO 13485, a milestone on the road to CE marking and market approval by the FDA in the US. BioStock contacted the company’s CEO Hanna Sjöström to find out more about what this means.

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.

Hanna Sjöström, CEO Neola Medical
Hanna Sjöström, CEO Neola Medical

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.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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