The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).
With international regulations for medical products becoming more rigorous, medical translation is becoming an essential component of successful product exportation and global system integration.
Westborough, MA – November 5, 2014, GlobalVision International Inc., a leading provider of technical translation services has released a new whitepaper covering the best practices in medical translation and localization. It helps life-science companies achieve accurate translation. Medical Translation Whitepaper Constituted of 5 real life case studies, this whitepaper addresses the difficulties that medical and Read More »
When it comes to medical documents translation, variations in procedures can make localization a daunting task for any medical-device manufacturer, medical software solutions provider, pharmaceutical company, clinical research organization or healthcare services provider.
The US Government recently released the Healthcare.gov app in Spanish at https://www.cuidadodesalud.gov/es/.
Immediately after its release, NBC News, among others, published an article about the quality and problems that plague the site. We have taken some time to investigate the kind of problems that exist in the Spanish and these are some of the problems that we found:
With the continuing assault on pricing in the translation – localization industry, we are taking a few minutes this week to ask some pertinent questions. What happened to quality in localization and translation? And how can one get a quality result without exceeding the budget?
I was recently forwarded the following unsolicited comments from one of our clients to a colleague of his. The text is presented as is, except for edits between brackets to protect the identity and company affiliations. Bear through the advertisement to note the salient lessons. These pearls of wisdom should not be dismissed.
Spring is almost here and with it comes the deadline for medical device manufactures to conform to the new Medical Device Directive from the European Community, 2007/47/EC. Any medical device manufacturer selling products in Europe will have to consult with its notified body to learn of any impact the new directive will have on its products and to gain certification or obtain formal exemptions where qualified.
During a visit this week to a leading manufacturer of surgical robotic equipment, I was allowed to preview and experience their fascinating product. This company has effectively combined video, optics, robotics, software and computers to create a product beyond belief. You have to experience it to truly appreciate its abilities. It is mind-boggling! Within a few minutes of training, I was able to operate the robot arms and perform intricate functions with relative ease!
Translation Management Systems (TMS) are designed to host and facilitate localization and translation projects for all stakeholders– clients, translators, localizers, vendors and partners. They give users secure 24/7 access to project information and assets via a simple web browser and preferably require no software or administrative tasks from its users.
I was recently contacted by one of my clients who informed me that he was approached by a competitor of mine taunting the benefits of ISO13485 certification. This vendor stated that “Our Notified Body-endorsed risk management methods can help you eliminate the effort and expense of overseas distributor review”. They also proceeded to inform my client that they are “the only ISO13485 certified translation vendor in the entire world!”