Aug 26, 2021 | Health, Medical Translation
Following our last LATAM series blog post which focused on Venezuela, this week we are focusing on Colombia’s medical device regulatory pathway. In 2018, over 80% of Colombia’s medical device market relied on imported devices; from a monetary perspective, this equals...
Jul 28, 2021 | News, Regulatory
Singapore’s Health Sciences Authority (HSA) is seeking feedback on draft guidelines released on standalone medical mobile applications and qualification of clinical decision support software (CDSS). Based on the International Medical Device Regulators Forum’s (IMDRF)...
Feb 4, 2021 | Health, Language Service Provider, Medical Translation
There is no doubt that medical devices are vital tools that not only enhance quality of life, but also save lives. From invitro diagnostic devices (IVD) like HIV blood diagnostic tests and blood glucose self-testing to software as a medical device (SaMD) that have...
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...
