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 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 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...
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