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.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...
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...
CFDA Reform Scheme of the Classification System for Registration of Chemical Drugs
On March 4th of 2016, the China Food and Drug Agency (CFDA) officially launched their new classification system for chemical drugs. Under the Reform Scheme of the Classification System for Registration of Chemical Drugs (Reform Scheme), previously called the Drug...
Regulatory Submissions: FDA (US) Requirements for CDISC Standards
Beginning in December of last year, all clinical trials are required to adhere to CDISC Standards. The Clinical Data Interchange Standards Consortium (CDISC) is a global not for profit organization with a mission to develop global standards. Through standardized...
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...
Can Machine Translation Be Used in Life Science Translations?
Machine translation (MT), I know what you are thinking when you hear that phrase. Machine translations translate words not language. While that may be true, machine translation is making leaps and bounds over the last few decades. People are using machine translation...
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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