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