How can life sciences companies ensure that they are providing accurate, efficient, reputable translations for the communities they support? The key is to engage a language solutions partner with the proven industry knowledge and linguistic expertise needed to meet the stringent requirements of their global content.
Translation Challenges: Medical Devices
For medical device companies, translation needs are diverse. From a Summary of Safety and Clinical Performance (SSCP) to operating, maintenance, or installation manuals, the stakes are high when it comes to providing accurate instruction and compliance materials. Companies often struggle to find language solutions partners with the technical expertise they need to translate these critical documents. And the same holds true for both Pharmaceuticals and Contract Research Organizations (CROs).
Translation Challenges: Pharmaceuticals and Contract Research Organizations
The pharmaceutical industry is subjected to some of the strictest standards of translation accuracy across any industry—not to mention that time is of the essence. Drug companies must get their products to consumers as quickly as possible to cover the high costs of research, development, and testing and take necessary action from products in the field (Recalls, Adverse Event Reports). Companies need language solutions partners that understand these time constraints but are still able to deliver high-quality translations every time.
Compliance poses another challenge. Recent EU medical device regulation (MDR) and in vitro diagnostic regulation (IVDR) require device manufacturers to adhere to a new set of compliance standards. And the penalties for noncompliance can be significant. In fact, products can be pulled from the market as the result of a failure to meet these standards. Over time, ignoring these translation requirements can lead to serious inefficiencies, profit loss, and hefty fines. For a summary of what’s changing, and examples of the implementation challenges that have already emerged, check out our EU Medical Device Regulation eBook.
By focusing on effective language solutions, you can reach more consumers and deliver better-quality products while adhering to tight deadlines and strict compliance standards. Life sciences corporations that want to compete globally in their highly regulated industry must rely on the support of comprehensive language solutions. Take CROs, for example. Global clinical trials must follow meticulous processes to ensure research results are of the highest quality. This process must include localization of your materials for international study sites, and linguistic validation of patient questionnaires.
United Language Group provides localization, translation, and interpretation solutions with medically qualified language support. ULG has provided full translation and localization solutions for leading CROs, including:
- Case report forms (CRFs)
- Product manuals, labeling, packaging inserts, and instructions for use (IFUs)
- Clinical trial protocols and regulatory documents
- Advertising, recruitment, and marketing materials
- Linguistic validation of ePRO/eCOA
- And more
Actionable Solutions for Improving Your Translation Capabilities
Finding a language solutions partner with linguistic expertise and extensive industry knowledge is crucial. With the right language solutions partner’s help, you can ensure that your products and services meet the most up-to-date regulatory requirements while appealing to global markets. Look for solutions providers that work with your internal teams to optimize your user experience, marketability, accessibility, profitability, and regulatory compliance, including International Organization for Standardization (ISO) Quality and Information Security Management System Standards.
ULG takes the lead with subject-matter expert translations in more than 200 languages. We maintain an unwavering commitment to best-in-class quality language solutions delivered with personalized customer care.
In addition, ULG contracts with research organizations to provide accurate linguistic translations, including clinical outcome assessments (COAs), pharmacological studies, and informed consent forms (ICFs). Linguistic validation ensures that all translations are culturally appropriate and accurate, and our experts work diligently to ensure that your products make it to market on time and in compliance.
To learn more about ULG’s translation solutions, we encourage you to speak with one of our experts.