INTRODUCTION: One of Italy’s leading pharmaceutical companies, which specializes in diagnosis and research, commissioned us, through its communications agency, to provide multilingual translation of specialized content related to one of its medical devices.
CUSTOMER’S GOAL: The customer, a leading company on both the Italian and international markets, needed a multilingual technical-scientific translation for a device headed for the medical and pharmaceutical market.
The translation not only had to be accurate and meticulous with regard to language, terminology and niche sector expertise, but also compatible with the regulatory requirements of foreign target markets.
With 13 target languages required, this meant strictly adhering to the most up-to-date regulations, standards and laws applicable in the various export countries: from the QSR (Quality System Regulation) and the Food & Drug Administration (FDA) authorizations in the United States, to the EU’s recent strengthening of all regulations applicable to medical devices, due to the COVID-19 pandemic, in the first half of 2020. It also meant adhering to the EU’s upcoming MDR (Medical Devices Regulation), now postponed to 2021.
CUSTOMER’S REQUEST: The specialized translation covered manuals, guides, flyers and product sheets regarding a blood glucose monitoring device in 13 languages:
Continuous glucose monitoring (CGM) systems incorporate wireless radio frequency technology, sensors and transmitters to provide specific information on patient blood glucose levels over 24 hours, providing a complete picture of blood glucose trends.
They are sophisticated, high-tech devices that are delicate and crucial to patient care, so they require extremely precise, skillful management of accompanying documentation.
The end customer also requested heightened attention to the specialized medical terminology called for by regulations in the various target markets.
This translation project involved many complex challenges.
Way2Global has an extensive network of translators specialized in medical and scientific translation, consolidated by over 30 years of experience in the field and continuous training and refresher courses.
This knowledge base enabled us to swiftly assign the project to a team of 13 native-speaking translators, all qualified and specialized in the medical and scientific field, guaranteeing the customer a customized solution and first-rate expertise.
In compliance with our ISO 9001 and ISO 17100 standards, the work team included a structured, integrated selection of translators, proofreaders, linguists and quality control staff, managed and coordinated by a senior project manager to ensure meticulous, efficient and timely management of the job.
Following a rigorous feasibility study, the work cycle was tailored to the customer’s specific needs and the translation, revision, QA and regulatory compliance stages were then monitored through constant direct informational dialog with the end customer.
To ensure full compliance with technical terminology, in addition to the regulations applicable to these devices in the medical and scientific sector, we adhered to the customer’s own customized terminology references and databases.
The customer received translation of manuals, guides, flyers, and technical data sheets to be supplied with the diagnostic device within the right timeframe for exporting the product to the target countries.
Our proven translation service specialized in the medical and scientific sector produced a top-quality, compliant and highly satisfactory result.
This solution, customized to the needs of the pharmaceutical company, once again satisfied the customer’s expectations, as confirmed by their feedback:
“I would like to take this opportunity to thank you for the professionalism and promptness with which you have always handled our requests (often at the last minute!).”
Event & Communication Account Manager