In the dynamic landscape of the life sciences industry, collaboration can be key to overcoming complex challenges and delivering exceptional results. Recently, Avantpage Life Sciences and EmTex Life Science joined forces to address an MDR compliance challenge presented by TEAC Europe GmbH, a leading medical imaging solutions manufacturer. This collaboration exemplifies the power of strategic partnerships in providing comprehensive, one-stop solutions tailored to the needs of our clients in this highly regulated sector.
MDR Compliance and Translation
TEAC Europe GmbH approached Avantpage Life Sciences with a specific request. They needed their most recent Instructions for Use (IFU) translated into five languages, but also needed support with the crucial step of checking MDR compliance with EU standards. As the source text is written at TEAC’s headquarters in Japan, ensuring MDR compliance with Medical Devices Class 1 EU regulations is essential. TEAC typically conducts MDR compliance checks in-house but, in this instance, requested that Avantpage include the task in the project scope. Given the crucial nature of both MDR compliance and linguistic accuracy, Avantpage leveraged their partnership with EmTex Life Science to tackle this challenge head-on.
Step One: MDR Compliance Check
EmTex Life Science, a provider of medical writing and communication services based in Belgium, brought over two decades of experience in regulatory medical writing to the table. Their EU regulatory compliance specialists meticulously reviewed the English text against EU Medical Device Regulation (MDR) standards, ensuring that the content met the necessary requirements.
Step Two: IFU Translation
Once the English text received the MDR compliance stamp of approval from EmTex Life Science, Avantpage’s team of expert linguists translated the IFU into five languages: French, German, Italian, Spanish, and Turkish. As subject-matter experts in the field, Avantpage’s teams ensured linguistic accuracy and cultural nuances were preserved throughout the translation process.
In addition to translation, Avantpage’s graphic design team played a crucial role in the project by reformatting the translated files, ensuring consistency and readability across all languages. The result was a set of IFUs that not only met MDR compliance standards but also provided clear and accessible instructions to end-users in diverse linguistic markets. Beyond delivering the translated IFUs, Avantpage went the extra mile by creating a post-project glossary for use on future TEAC Europe GmbH projects and updates.
The Partnership
Avantpage Life Sciences was delighted to partner with EmTex Life Science on this MDR compliance project as our respective company offerings are the perfect complement to one another. Both companies are trusted partners for the life sciences industry, and both are focused on what we know we do best. Avantpage’s linguists are experts in clinical trials, pharmaceuticals, medical devices, and biotech, and the company is ISO-certified. EmTex Life Science brings a wealth of expertise in medical writing and communications services to the table, with writers specializing in preclinical, clinical, pharmacokinetics, pharmacodynamics, and quality of life. Through their EmTex Academy, they also offer professional courses within the life science industry, further demonstrating their commitment to excellence and knowledge sharing.
Client Satisfaction
Client testimonials speak volumes about the success of the collaboration between Avantpage and EmTex Life Science. Andreas Koller, Sales and Marketing Manager at TEAC Europe GmbH, praised the seamless experience and expressed confidence in Avantpage’s continued support in navigating complex regulatory landscapes.
“This was the first time we worked with a different vendor and also the first time we asked an external partner to check MDR compliance. Things were very smooth with Avantpage, who will soon begin assisting with the complex IFU update process.”
– Andreas Koller, Sales and Marketing Manager at TEAC Europe GmbH
In conclusion, the partnership between Avantpage and EmTex Life Science exemplifies the power of collaboration in the life sciences industry. By leveraging each other’s expertise, these two industry leaders provided TEAC Europe GmbH with a comprehensive MDR compliance solution that addressed their unique challenges and exceeded expectations. As the life sciences landscape continues to evolve, partnerships like this will play an increasingly vital role in driving innovation, compliance, and success for clients worldwide.
