IVDR Summit

IVDR Summit

Today, our CEO Sofia Nordgren represented Kickfile and Devicia in two panels discussing Clinical Evidence and Companion Diagnostics as part of the IVDR Summit. Thank you Swedish Labtech for having us!
New partner company – Lea Reg

New partner company – Lea Reg

We are proud to present the latest addition to our group of partner companies: Lea Reg Medical device and IVD regulations often require local presence to place products on respective market. With offices in the EU, UK, and US, Lea Reg acts as your designated local...
Guld Bio – Galan!

Guld Bio – Galan!

Thank you very much SwedenBIO for a fantastic evening at Guld Bio-Galan! Hugely inspiring to see the diversity, quantity, and quality of life science research springing from our long and narrow country.
Episode 4 – NOTIFIED BODIES, EUDAMED & MRA

Episode 4 – NOTIFIED BODIES, EUDAMED & MRA

In this follow-up episode of MDR-podden, your host Sofia Nordgren and Helena D., Head of Department for Medical Devices at the Medical Products Agency, discuss topics such as the designation of notified bodies, EUDAMED and how Brexit and the lack of mutual recognition...