Medical Translation Insight

Friday special - save 75% on "GCP for Medical Device Trials: Upcoming Revisions to ISO 14155"

2009-11-06T01:57:00.002-05:00

An important standard for conducting medical device research is changing. How will it affect you?Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently

Quality is dead - long live measurable quality

2009-11-05T05:33:00.003-05:00

Let's all say it together: Translation quality is dead.You don't have any quality unless your organization can define and measure the quality of its translations. Expressions like "quality is a given" and "we don't sacrifice on quality" are just empty words - unless and until their backed up by proof.So why don't more organizations measure their translation quality? Beyond the fact that many

Progress to PIM remains slow for pharma

2009-11-04T08:35:00.001-05:00

EMEA's Product Information Management (PIM) system was conceived in late 2005 to to help improve the management, exchange, quality, and consistency of published product information. PIM was setup to be used either within, or outside, the eCTD.Currently in a pilot phase where PIM submissions are only accepted subject to prior discussion with the EMEA. The goal is that by the end of 2011, all

Regulatory requirements for selling medical devices in the Ukraine

2009-11-03T05:44:00.004-05:00

Even though Ukraine is the second largest country in Europe and has a population of close to 50 million people, its domestic market for medical equipment and supplies is estimated at only US$281 million. Small, for sure, but the market is expected grow at a CAGR of 6.4% annually. Increasingly, the country is gaining the attention of medical devices companies looking for new and emerging

PRO Forum taking place in Philadelphia

2009-11-02T11:35:00.000-05:00

A patient reported outcome (PRO) measure is a broad term describing any measurement about the patient's health that has come directly from the patient - anything from multidimensional questionnaires assessing health-related quality of life to assessments of single symptoms.As regulatory agencies increase their support of PRO measures in clinical trials as a basis for submissions, PRO data is

French fight to narrow digital divide

2009-11-01T06:38:00.006-05:00

To many people around the world, using English mixed in with their native tongue is almost second nature. As new terms (particularly in the area of technology) are first coined in English, almost all languages find themselves "invaded" by Anglicisms.But for many folks, this widespread influence of the English language isn't welcome. And nobody has been as consistent (and determined) to fight this

Translation moves to smartphones

2009-10-30T07:53:00.007-04:00

Smartphones are getting, well, smarter. Whether you want to use your mobile phone as a medical device or as an on-the-fly translator, there's "an app for you".Recently, translation applications available on the iPhone have grown exponentially. There are now more than a dozen translation applications in Apple's AppStore. Some are language-specific and some are task specific. Two promising new

Friday special - save 75% on "Hazard Analysis for Medical Devices Under IEC60601 and ISO14971"

2009-10-30T01:55:00.001-04:00

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.This

TRADOS and MS Office - what's the interaction?

2009-10-29T06:35:00.001-04:00

With every new release of MS Office, anxiety takes hold amongst translation service providers: What are the implications of this new version with existing software and tools, particularly TRADOS' translation memory application? How will we deal with bugs; what plug-ins might be needed?Office 2007 files, while not necessarily "new", are no exception: .docx files in particular are no friends of

eCTD 2010 in Berlin

2009-10-28T05:37:00.001-04:00

eCTD 2010 is the second annual conference dedicated to European eCTD developments. This year's agenda (all content in German) looks really interesting. Updates on the state of e-submissions throughout Europe coupled with participation from regulatory heavy-weights from industry promise to make this a terrific event. There is also a session on RPS and plenty of opportunity for networking. And all

Of birth control, law suits, and translation

2009-10-27T10:49:00.005-04:00

Manufacturers of pharmaceutical drugs in general and birth control pills in particular are used to law suits. So Bayer probably wasn't all that surprised when it first became the target of law suits. But over the past six months, law suits around Bayer's Yasmine and Yaz oral contraceptives are mounting daily - more than 125 legal actions are on the books.When the law suits fly, all manner of

TM-Europe International Conference wrap-up

2009-10-26T09:37:00.002-04:00

Fall is the time for conferences... After reporting on the Medical Localization Roundtable at Localization World and RAPS' Medical Devices & IVDs: A Practical Approach to the Japanese Market event, here are some highlights from TM-Europe International Conference 2009 in Warsaw, Poland. ForeignExchange's Sandra La Brasca attended the conference, which this year was focused on quality management as

Trials and tribulations of a medical translator

2009-10-25T09:47:00.000-04:00

Being a medical translator is hard work. Don't believe me? Just check out this video...Enjoy and have a good weekend![Via medicaltranslt's Twitter feed]For expert medical translation services, ask about ForeignExchange's specialized services for medical device and pharmaceutical companies.

Turn your Xbox 360 into a cardiac research tool

2009-10-23T06:49:00.001-04:00

We love it when you can make your toys do double-duty as business or personal health tools. After justifying the purchase of a Nintendo DS by way of using it as a glucose meter and multilingual dictionary, you can now set your eyes on getting an Xbox 360.Medgagdet reported that a researcher at the University of Warwick has been using an Xbox 360 to model and simulate cardiac arrhythmia in the

Friday special - save 75% on "Pre-IDE Submissions and Meetings: Best Practices"

2009-10-23T01:52:00.001-04:00

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this

Report from Medical Localization Roundtable in Santa Clara

2009-10-22T06:29:00.001-04:00

Tuesday's preconference day kicked off Localization World 2009. The Medical Localization Roundtable was attended by about 30 people, roughly the same as the June event in Berlin.While the expanded format of four sessions did little to attract additional attendees, the quality of the discussions was terrific. One of the standout sessions was the joint presentation by Elizabeth Judd-Cummings of

RAPS Japan conference wrap-up

2009-10-21T11:01:00.004-04:00

The Regulatory Affairs Professional Society (RAPS) hosted a two-day conference last week, focusing on Japan regulatory filing. It was well attended by medical device and IVD company representatives and industry consultants.The conference agenda covered diverse topics, from reimbursement strategies for IVD companies, to QMS applications, cultural tips for doing business in Japan and updates to the

Pharma blogs - doomed if you do, doomed if you don't

2009-10-20T05:55:00.000-04:00

Social media is all the rage. Despite recent indications that FDA is realizing this, medical device and pharmaceutical companies are still generally scared of social media.The following quote from John Mack, as quoted in Healthcare Social Networking: Is pharma ready to join the conversation?, in nicely sums up the prevailing sentiment:"Pharmaceutical marketeers must feel like they are doomed if

Managing the shift to eCTD

2009-10-19T09:00:00.004-04:00

While the electronic Common Technical Document (eCTD) is not yet a truly global standard, it is surely moving in that direction.For sponsor organizations, the challenges in making the transition to electronic submissions lie in two areas, specifically: convincing upper management and implementing a "clean" eCTD process.Support from upper management is vale to the success of the eCTD

Free translation, localization tools

2009-10-18T05:45:00.001-04:00

Everybody likes a freebie, right?When it comes to buying translation tools, it's easy to spend hundreds or even thousands of dollars/euros/pounds. So it's nice to see L10NWorks' collection of free translation and localization tools.Some of the tools, do one specific thing. For instance, the Portuguese Reformer utility adjusts strings written in old-world Portuguese to be compliant with new

Certification for medical interpreters becomes reality

2009-10-16T08:54:00.001-04:00

We have previously reported on efforts by the International Medical Interpreters Association (IMIA) to facilitate interpreter access to non-English-speaking patients in the United States. IMIA's Guide on Translation was well received and the organization's annual conference is a must-attend event for anybody associated with medical interpreting.So it is understandable that the IMIA folks are

Friday special - save 75% on "Risk-Based Software Validation for Medical Devices"

2009-10-16T01:40:00.002-04:00

It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent.Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look

See you at Medical Localization Roundtable?

2009-10-15T06:55:00.005-04:00

If you have attended past iterations of the Medical Localization Roundtable, you know that this is a unique opportunity to get together with translation managers from other device and drug companies. In fact, the Medical Localization Round Table is the only forum for pharmaceutical and device companies to discuss translation and localization issues. For this latest iteration, the event is

Japan regulatory clearance - avoid a shock to the system

2009-10-14T10:32:00.001-04:00

In Japanese, "Nemawashi" refers to the binding of a plant's roots by a gardener when moving a plant. Nemawashi is a long and painstaking process by which each root is carefully cut and bound one at a time, to avoid shocking the plant. Only after all roots are cut and bound individually can the plant be moved.The same concept seems to apply when medical device and in-vitro diagnostic companies

Controlled authoring for faster, better, less expensive translations

2009-10-13T06:49:00.004-04:00

"Garbage in, garbage out" goes the old warning: If the source text is of poor quality, expect the translated text to be no better. English is the main language used by global medical device and pharmaceutical companies. But drug and device companies must provide instructions for use in the native language of the countries to which they export. Up until a few years ago, little thought was given to