Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Innovation: A Top Priority for the Life Sciences Industries
Yesterday, FDA Commissioner Scott Gottlieb made a statement on the new steps that the FDA is taking to improve innovation in medical devices…
The Real Challenges and Pitfalls of Machine Translation
I found a really interesting article this week, that I thought was worth bringing up. It is based on a study of phrases utilized in clinical settings, and the effectiveness of a free machine translation to bridge communication gaps between patient and caregiver....
China Announces Change to Clinical Trial Requirements
Earlier this week, China's State Council announced plans to allow clinical trial data from other countries. As one of the largest pharmaceutical markets in the world, they are looking to bring in new, innovative therapies quicker. This comes on the heels of changes...
Tips for Establishing and Maintaining a Quality Management System (QMS)
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...
Book A Translator Service for the Life Science Industries
As we have discussed before, translators are increasingly being used in clinical settings. Utilizing interpreters, whether via phone or in person, enables patients or clinical trial participants to fully grasp information given to them. This allows clinicians to...
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 text...
Looking at Healthcare Needs for an Aging Population in Japan
Earlier this month we were looking at some of the factors affecting the life science industries today. Undeniably, the world’s aging population is changing the priorities of health care delivery and infrastructure all over the globe. With an older population, there's...
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" Initiative. This...
The Evolving Landscape of Life Science Translation
The life science sector is continually evolving and becoming ever more globalized. What used to work as a business model is progressively challenged by cost pressures, operating performance challenges as more mergers and acquisitions take place, and global trends in...
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CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com