May 3, 2021 | Classification System, e-Labeling, EMA, Health, Medical Translation, Quality, Regulatory
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
Sep 23, 2020 | News, Regulatory
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and...
Sep 18, 2020 | Machine Translation, Medical Translation, Medical Writing, Regulatory, Terminology
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...
Apr 24, 2020 | News, Regulatory
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
