Kickfile News & White Papers

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News and whitepapers

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 […]

White paper: Economic Operators, are you prepared?

Along with the MDR, more stringent requirements are introduced for Economic operators involved in the distribution of medical devices to the European market. On December 1, 2020 the actor registration module of EUDAMED has been made available. In this white paper, the first in a series of papers co-authored by Clarvin, Devicia, Kickfile and Morris […]

All the MedTech experts You need – All in one place

With seamless support from 5 companies working as one, in all matters relating to medical devices – Strategy, Quality, Regulatory, Biocompatibility, Medical Writing, Clinical, support to the board/management team and more – we’re looking forward supporting you any way you need.

Kickfile and Almi Företagspartner in a close collaboration

Thank you Almi Företagspartner for our journey together so far, we are looking forward to further collaborations.

MedTech compliance made easy

Read the first interview with our CEO Sofia Nordgren, “Through Kickfile we offer complete systems for e.g. clinical evaluations and clinical investigations"