Understanding the New EU MDR Update and Its Effect on Medical Device Translations
The EU is rolling out a new set of regulations for medical devices by 2024. Here we explain how the MDR effects medical device translations.
When paired with our advanced translation technology, we have the ability to localize any content type, including:
Adverse Event Reporting
Case Report Forms (CRFs)
Chemistry Manufacturing And Controls (CMC)
Clinical Trial Content
Clinical Trial Protocols
Directions for Use (DFU)
Drug Packaging And Labeling
Informed Consent Forms (ICFs)
Instructions for Use (IFU)
Legal And IP Materials
Pharmacology & Toxicology Reports
Summary Of Product Characteristics (SmPC)
Translation Of Scientific Journal Articles
Manufacturing SOPs & Production Manuals
Material Safety Datasheets (MSDS)
New Drug Authorization Applications
Package Inserts & Information Leaflets (PILs)
Patents And Contracts
Patient Recruitment Materials
Patient Reported Outcomes Forms (PROs)
Patient Surveys And Diaries
Quality control in the life sciences industry isn’t just a luxury, it is a necessity. Because of this, we have an unwavering commitment to quality assurance throughout the entire translation workflow.
We are proud to employ an ISO 9001:2015 certified process to ensure the utmost accuracy and clarity for all life sciences translations. Language Intelligence works only with native-speaking, in-country, and medical linguistic experts to meet all of your language localization requirements. Our quality standards, mixed with deep industry experience and expertise, will provide you with translation solutions you can trust.
Additionally, we can provide certified translations and translators, if required.
What is a certified translator?
An individual who has passed a certification exam to verify his or her professional translation and linguistic skills in a certain language.
What is a certified translation?
A translation accompanied by a signed statement attesting that the translation is accurate and complete to the best of the translator’s ability.
Language Intelligence has over 30 years of experience providing life science translation services to worldwide leaders in the life science industry. We combine accuracy and technical precision to achieve unparalleled high-quality translations and end-to-end language solutions for global pharmaceutical companies, biotechnology firms, medical device manufacturers, and healthcare providers.
Our streamlined process allows for life science translation and localization into over 150 of the world’s languages and can encompass all of your regulatory, clinical, patient, and commercial needs. We can ensure your organization is equipped to reach new markets and can comply with any regulatory requirements, while keeping cultural considerations in mind, for every stage of your product’s life cycle.
Succeed in international markets and deliver better outcomes with pharmaceutical translation.
Support your device abroad with medical device translation of regulatory documents, software, and other related materials.
Communicate effectively with patients and care providers around the world with healthcare translation.
Since our inception in 1988 Language Intelligence has been following a documented Quality Management System. In 2009 we chose to certify our Quality Management System to the ISO 9001:2008 standard as proof to our customers of how serious quality assurance is to us as a company. We have since updated our certification to ISO 9001:2015, and we plan to continue to maintain certification moving forward.
We chose the ISO standard because we believe that it is the most comprehensive of all of the current guidelines and standards available to the translation industry, and because it is a standard that many of our customers are familiar with, or have implemented themselves.
An optimized life science translation and localization process reflects the perfect mix of skilled human translation and advanced technology.
Language Intelligence is proud to use our proprietary translation technologies to decrease turnaround time, control costs, and mitigate risk.
We are constantly working to evolve our technology to support our skilled life science translators while improving the quality and accuracy of your content while streamlining project administration.