With a recent societal emphasis on mental wellbeing, mental health focused telehealth apps have exploded in popularity, including Sanvello, Meru Health and Happify. Offering programs for people with depression, anxiety and stress among others, these affordable and...
Linguistic validation is a process of translating, reviewing and validating the accuracy, reliability, and conceptual equivalency for patient reported clinical outcome assessments (COAs). CSOFT Health Sciences manages the entire life cycle of an extended process of...
Nuance, culturally specific idioms, and unique terminology are part of any language, but in an industry where mistranslations could endanger human life, how does back translation ensure high-quality translation of patient diaries? In healthcare, patient diaries are...
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...
Let’s talk about quality! When it comes to translation there are two types of quality, the end product that is being delivered and the process it goes through to get there. Today we are going to look at the latter. Quality management systems, used by industries...
Published in 2016, ISO 13485:2016 is in its third edition. ISO 13485:2016 comes on the heels of the ISO 13485:2003. Beginning in March 2016, there is a three-year transition period which comes to an end on February 28th 2019. These regulatory requirements undergo...
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