Kickfile News & White Papers
Your shortcut to the latest insights
Get the latest updates and insights in the field of regulatory compliance. Subscribe to our newsletter and make sure that you don’t miss out on anything.
News and whitepapers
Today you can read about or Sofia Nordgren, CEO at Kickfile and CCRO at Devicia AB – Your Medical Device CRO in Dagens industri. Sofia shares the idea behind the recently released MDR-podden that she has initiated together with SwedenBIO, her advice on how to tackle the lack of Notified Bodies that are qualified under […]
MDR PODDEN – HEAD OF DEPARTMENT FOR MEDICAL DEVICES AT THE SWEDISH MEDICAL PRODUCTS AGENCY IN THE STUDIO
In SwedenBIO‘s podcast studio, our CEO Sofia Nordgren is accompanied by Helena D., Head of Department for Medical Devices at the Swedish Medical Products Agency at the recording of the second episode of MDR podden. Stay tuned for the next episode of MDR podden – the podcast that helps you navigate through the MDR.
We are proud to announce that our partner company Limulus Bio will be hosting the biocompatibility conference Biocompatibility Matters 2022. The conference will bring people together to inspire, educate and network May 4-5 2022 in Copenhagen, Denmark. Register your contact information at the conference page to stay tuned for more information, see you in Copenhagen!
INTRODUCTION The advancements in technology and digital revolution of the healthcare and medical device industry have created a vast amount of technical solutions, software applications and other software being used for medical purposes. The legal framework regulating medical devices hasn’t kept up with the rapid movement and advancements in technology, creating an urgent need for […]
Thank you Nordic Life Science Days for giving us the opportunity to contribute to your Super Session 6: The New Cross-Industry Playground 🤝. Our CEO at Kickfile and Director of Regulatory Affairs at Devicia AB – Your Medical Device CRO, Sofia Nordgren co-hosted the session and shared her experience on the topic.
Nordic Life Science Investment Day: Modernizing the Regulatory Landscape – Where Are We & How Did We Get Here? The 21st of April, Sofia Nordgren our CEO at Kickfile and Director of Regulatory Affairs at Devicia AB – Your Medical Device CRO will be co-hosting at the Nordic Life Science Investment days. Sofia will share […]
The medical device industry is significantly impacted by Brexit, primarily due to the change in the legal landscape. Notably, the departure by Great Britain from the EU medical device regulatory framework leads to the following