Last summer, Lybe Scientific got its first product registered as a CE-marked IVD medical device fulfilling the requirements set by In Vitro Diagnostic Directive (IVDD). The company built an ISO 13485 compliant QMS in a short time with the help of Innokas’ QARA team and got registered as a legal manufacturer of in vitro diagnostic medical devices. This was a key milestone for further sales and marketing of Lybe Scientific’s products for diagnostic purposes.
Lybe Scientific is a Norwegian start-up founded in 2021. The company focuses on the development of universal cost-effective sample preparation solutions that cover a wide range of nucleic acid-based diagnostic applications. The work is based on the patent-pending technology that originates from the research by the Norwegian University of Research and Science (NTNU) groups within clinical molecular medicine, nanotechnology, and chemical engineering.
To get to the markets in Europe, the solutions developed by the company need a CE Mark certification and regulatory approval as in vitro diagnostic devices (CE IVD) in compliance with EU regulations. The project to reach the approval was planned to be carried out with a very tight schedule and required the company to put in place an ISO 13485 compliant Quality Management System (QMS) matching the company’s needs. To make all of this happen, Lybe Scientific decided to continue to work with Innokas Medical’s QARA specialists, which had consulted the team already earlier whilst the project was still developed under NTNU Technology Transfer AS, a company owned by the university and health authorities and aiming to lead innovations into reality.
“The efficient workflow and competencies of Innokas Medical were the most important reasons to choose the team. Based on the earlier good cooperation it was natural for us to continue working together”, says Tonje Steigedal who’s heading Lybe Scientific.
Sharing information and learning together
To leverage the best of knowledge and skills of all members, the Innokas QARA specialists worked together as a team throughout the project’s tight time span, which was packed with a massive number of tasks to be done.
Tonje comments on the ways of the teams cooperating: “The world has changed a lot within the last year or so, with the digital platforms taken in use. Normally we would have expected there to be physical workshops and getting together for several days, but it has worked nicely in having meetings in Teams and people continuing discussions and sharing documents remotely in between.”
Despite the very demanding project and schedule, the Innokas team praised the seamless cooperation, positive atmosphere, and great spirit among the whole workgroup. According to Innokas’ specialists, it was like the two teams had always worked together and they were very pleased to be able to help such a proactive customer having the perfect attitude to get things done.
“This was an extremely interesting project for us. Lybe was terribly keen on learning throughout the project and that’s also the inclusive way of working we have. It’s about learning together and finally helping our customers to tackle these processes on their own. Keeping the projects and all the information to yourself is not fruitful for either party”, summarises Satu Päiväläinen, Innokas Medical Specialist, Clinical Affairs and IVD.
As a result of the cooperation, Lybe Scientific has the needed QMS in place, and upskilled personnel that can manage the system autonomously. The project team was also able to collect and create the technical file needed to show compliance to relevant IVD regulatory requirements. Consequently, the company entered the IVD market as planned.
And the collaboration continues. The two companies have now started working together to make sure that Lybe Scientific’s product complies also with the new In Vitro Diagnostic Regulation (IVDR) set to be replacing IVDD next year.
Additional information:
