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

Biocompatibility Matters 2022

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!

Coming soon: MDR Podden

We are happy to share with you that our CEO, Sofia Nordgren, soon will launch MDR-podden together with SwedenBIO. Visit SwedenBIO to read more about the news here!

White paper: Medical Device Software – Understanding the impact of the MDR

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!

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

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 […]

White paper: Brexit and its impact on the MedTech industry

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

Nordic Life Science Investment Day: Modernizing the Regulatory Landscape – Where Are We & How Did We Get Here?

The 21st of April, our CEO at Kickfile and Director of Regulatory Affairs at Devicia AB will be co-hosting at the Nordic Life Science Investment days. Sofia will share her knowledge on The New Cross-Industry Playground session and speak about Modernizing the Regulatory Landscape, answering the questions of where we are & how did we get here? In the […]

CEO of Kickfile: part of the technical committee for laboratory medicine (SIS/TK 331)

The technical committee for Laboratory Medicine contributes to the development of standards that provides safe and efficient systems, routines within clinical laboratories and safe products for in-vitro diagnostics. The work aims to increase patient safety by developing standards that make diagnoses and analyzes more reliable. The European Standards (ES) are a prerequisite for manufacturers to […]