Domain Expertise
The regulatory hurdles faced by pharmaceutical, medical device and healthcare companies when releasing new products can increase exponentially when entering new markets. Generic, misinformed, or non-compliant translations can hinder your regulatory approval, delaying your time-to-market; give target customers an unfavorable and inaccurate impression of your company and products; and worse, cause adverse events through misuse of your product. These could result in expensive recalls and the tarnishing of your company’s image.
MedL10N is the only Asia-based language service provider with a sole focus on the Life Sciences. As such, we understand the unique needs and requirements of the highly regulated biotech, medical device, healthcare and pharmaceutical sectors. Our management team has more than 25 years of expertise in producing multilingual technical documentation for international markets in the Life Sciences industry. Combined with our commitment to using experienced, in-country translators with subject-matter expertise, along with our ISO-certified quality metrics, rapid delivery, comprehensive risk management procedures and competitive pricing, we regularly deliver on-time, compliant, and quality-driven medical translations for a number of Fortune 500 and Fortune 100 organizations in the Life Sciences industry.
Regulatory Expertise
Life Science companies face unprecedented hurdles in releasing products to new markets. Meeting stringent and complicated regulations, combined with extremely long application proceedings, make any delays extremely damaging.
MedL10N has vast experience in meeting the complex regulatory requirements for the following organizations, laws and bodies:
- Irish Medicines Board (IMB)
- Pharmaceutical Affairs Law (PAL, Japan)
- State Food and Drug Association (SFDA, China)
- European Union (EU)
- US Food and Drug Administration (FDA)
Our targeted and reliable localization solutions will ensure that your products are compliant with minimal delay, reducing your time-to-market and increasing your competitiveness in the global market.
Technical Writing Expertise
MedL10N provides end-to-end localization, terminology management, testing and software development solutions in 90+ languages. In particular, our specialties include:
Our two directors have over 25 years of hands-on experience in technical communications and localization in the Life Sciences sector.
- Tammy Werner has more than 15 years of experience in technical communications for the medical device industry. She joined MedL10N in 2009 from Beckman Coulter, a multi-billion dollar manufacturer of biomedical instruments, where she managed the production and localization of all instrument manuals and consumable labeling for their Miami production center.
- Uwe Muegge served as the Corporate Terminologist at Medtronic, the world’s largest manufacturer of medical devices and technology. He is also currently a member of the technical committee for terminology at the International Organization for Standardization (ISO) and teaches graduate courses in Terminology Management at the Monterey Institute of International Studies.
Quality
At MedL10N, we understand that quality is the number one priority when localizing medical documentation, labels, GUIs and IFUs for the international market. This is not only about presenting the most professional face to new customers looking for authenticity and reliability in their chosen healthcare, medical device or pharma product provider. It is also about ensuring 100% consistency and accuracy of expression across all documentation to avoid any adverse events that may arise out of product misues. MedL10N accepts only the best: best practices, best translators, and the best tools.
MedL10N:
- is ISO 9001 and ISO 13485 certified
- applies Six Sigma’s DMAIC cycle to continuously improve all steps of localization
- incorporates FMEA processes to mitigate risk
- uses repurposed SAE J2450 quality metrics to eliminate translation errors
- only employs experienced in-country translators with subject-matter expertise
- closely monitors each step of the translation and localization process
- stresses the importance of a properly applied terminology management strategy
- employs automated tools, when applicable, to ensure translation accuracy and efficiency
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