Quality

In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies

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...

Tips for Establishing and Maintaining a Quality Management System (QMS)

Oct 5, 2017 | Quality

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...

Medical Device Quality and ISO 13485:2016 Certification

Sep 21, 2017 | Quality

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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In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies

Tips for Establishing and Maintaining a Quality Management System (QMS)

Medical Device Quality and ISO 13485:2016 Certification

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