by Mikaela | May 26, 2021 | News
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!
by Mikaela | May 18, 2021 | White papers
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...
by Mikaela | Apr 22, 2021 | News
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...
by Mikaela | Apr 13, 2021 | News
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...
by hemsida365 | Mar 17, 2021 | White papers
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: • Product registration with...
by Philip | Feb 22, 2021 | News
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...
by Philip | Feb 11, 2021 | News
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...
by hemsida365 | Dec 4, 2020 | White papers
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...
by hemsida365 | Oct 19, 2020 | News
Please come visit us at our new office at Riddargatan 12, the full-service MedTech competence group. https://goo.gl/maps/1SKXA29ZzhEa8BAY7 With seamless support from 5 companies working as one, in all matters relating to medical devices – Strategy, Quality,...
by hemsida365 | Oct 19, 2020 | News
Thank you Almi Företagspartner for our journey together so far, we are looking forward to further collaborations. Read the article to learn more about us (Länk: https://www.almi.se/nyheter/halland/kickfile/)
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