When it comes to translations, bend ‘m like Beckham.

With the 2010 World Cup kicking off in just four months in South Africa, soccer fever is starting to rise. Soccer aficionados will be glued to screens in every corner of the world to watch the high-quality drama unfold. In millions of houses spirited debates will ensue about what makes a team, a player or a coach good or bad. In other words: discussions about quality.

Translations and soccer do not seem to have a lot in common at first. But when viewed through the perspective of quality management system ISO 9001, they may have some surprising common ground.

ISO 9001 is a system that describes elements of a process that, when followed, increases a company’s chances to deliver a high quality product. Or a service, like translations or soccer.

Just like a translation provider, the World Cup is a business. It delivers a service (soccer) to a client (TV and stadium audience). And just like translations, the quality of its service is the result of a process that results in a certain outcome. An excellent translation of say, an IFU for a home glucose measuring device, will make the user understand the purpose and function of the device. An excellent soccer game may advance a team to the finals.

Let’s take a look at the five main pillars of ISO 9001 and how these elements could be applied to translations and soccer.

	Translations	Soccer
Quality system	Company organization	Club or team organization
Management responsibility	Quality policy Management commitment Planning	Commitment coaching and technical staff Playing style (offensive, defensive) Talent and stadium planning
Resource management	Qualified linguists, engineers, desktop publishers, project managers, other staff Localization tools and training	Qualified coaches, skilled players Transfer market, cultivating young talent through the team’s ranks Training camp Stadium exploitation Shirt sponsor
Product realization	Strategy, planning, process of producing translations	Game day. Strategy, planning, process of playing (and winning) a game
Measurement, analysis and improvement	Client feedback, internal audits, monitoring of data derived from translation process. Where can we optimize, improve quality?	Where are we in the rankings? How many goals have we scored? How many times do our opponents score on us? How many yellow and red cards do our players get? How often do we have injuries? How is the 4-3-3 system working, how did we do when we played 4-4-2? Where can we get better?

At the end of the World Cup, when you cheer (or not) for the team that triumphantly hoists the coveted trophy in the air, think about all the things the team did right –on and off the field– to end up with this quality result.

Excel Translations' quality assurance processes enable the company to meet and exceed the strict regulatory requirements and quality standards of its clients. We specialize in medical device labeling translation, diagnostic products labeling translation, pharmaceutical labeling translation, and life science labeling translation. Common labeling translation services include the translation of user’s guides, the translation of IFU, the translation of medical inserts, and the translation of user interface scripts. Contact us for more information about our medical translation services.

Italy — A New Ministry of Health Decree Should Simplify the Registration Process for Medical Devices

Effective February 6, 2010, all medical device manufacturers will need to comply with the Italian Health Ministry's revised decree regulating the registration of medical devices. The new decree, published on 21 December 2009, replaces the controversial decree of 20 February 2007 (Decreto del Ministero della Salute 20 febbraio 2007) which required medical device manufacturers, or their affiliates, to register their products in the Italian Ministry of Health Database, if the medical devices were to be sold in Italy. IVDs were excluded from this decree, since they needed to be registered through a separate process.

This new decree is meant to reduce the amount of data that has to be supplied by companies when re-registering products in several categories including class I devices and active implantable devices.

According to the Italian Ministry of Health, this new directive should simplify the requirements for the registration of medical devices. The deadline by which older products must be re-registered has been extended until 5 May 2010.

U.S. companies need to comply with the revised registration process.

The question, however, is whether or not the registration process for medical devices in Italy will indeed be simplified with this new decree.

Download your complimentary copy here.

Excel Translations' quality assurance processes enable the company to meet and exceed the strict regulatory requirements and quality standards of its clients. We specialize in medical device labeling translation, diagnostic products labeling translation, pharmaceutical labeling translation, and life science labeling translation. Common labeling translation services include the translation of user’s guides, the translation of IFU, the translation of medical inserts, and the translation of user interface scripts. Contact us for more information about our medical translation services.

Understanding European Language Requirements for Pharmaceuticals and Medical Devices

Countries within Europe have specific translation requirements for computer software, Instructions for Use (IFU), packaging, and other Medical Device and Pharmaceutical labeling. In this ever-changing regulatory and international market clearance environment, it is vitally important for you to have this information at your fingertips. Without it you are unable to proactively properly plan your international market clearance strategy. In addition to the language requirements there are trends and country-specific requirements for the medical device directives and pharmaceutical regulations.

A comprehensive, easy-to-understand matrix is available to help you understand the necessary European Language requirements for both Medical Devices and Pharmaceuticals. This helpful guide outlines the medical device and IVD language requirements, pharmaceutical language requirements, national requirements in addition to the device directives, and additional requirements and exceptions for pharmaceuticals.

Download your complimentary matrix here.

Excel Translations' quality assurance processes enable the company to meet and exceed the strict regulatory requirements and quality standards of its clients. We specialize in medical device labeling translation, diagnostic products labeling translation, pharmaceutical labeling translation, and life science labeling translation. Common labeling translation services include the translation of user’s guides, the translation of IFU, the translation of medical inserts, and the translation of user interface scripts. Contact us for more information about our medical translation services.