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Medical Device Quality and ISO 13485:2016 Certification

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...

Man vs Machine Translation: The Continued Debate

Quite a while ago we took a look at the role of machine translation (MT) in life science translations. It’s a hot topic of debate, and we can all see with a quick internet-based translation what the pitfalls are. These one-off quick translations of a block of...

The Evolving Regulatory Environment in Japan (PMDA)

At DIA in June of this year, Tatsuya Kondo, Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation on the future activities of the PMDA in Japan. In the presentation, Kondo discusses Japan’s “Rational Medicine”...

Rounding Out the Summer: Industry Events

As summer is quickly drawing to a close, I want to take this time to explore some of the many upcoming industry events. In such a fast-paced industry, the life sciences industries are an area that provides numerous opportunities for continued learning. Understanding...

e-Learning in the Life Sciences Industries – Best Practices

In our digitally connected world, e-Learning is being used ever more frequently as a method of information delivery. Utilized by industries around the globe, e-Learning allows for efficient and cost-effective continued learning and training opportunities. Localizing...