The regulatory landscape for medical devices is always evolving, so it’s critical to stay up-to-date to remain in compliance. Morningside’s regulatory translation team has expertise in country and region-specific requirements for product labeling, UDI and CE marking, 510(k) submissions and more. We’ve stayed ahead of the curve for over 20 years with in-depth knowledge of global medical device regulations and are recognized for our expertise regarding translation requirements for the EU MDR and IVDR.
In medical devices, mistakes can lead to a product recall or costly litigation. That’s why our commitment to quality is unwavering. Morningside employs ISO 13485, 9001 and 17001 certified processes and quality controls, as well as a 3-tier linguistic review process to ensure accurate translations. As an added step to mitigate risk, our proprietary algorithm – the Quality Reliability Indicator (QRI) – monitors projects, identifies areas for risk reduction and helps prevent errors before they happen, leading to reliable, repeatable outcomes.
Morningside gets ideas right, providing reliable language solutions at every stage of the product lifecycle. During development, clients rely on us for software localization and UI/QA testing. We also work with leading manufacturers to translate and file their patents internationally. When devices are ready to meet regulatory approval, we provide translation services for a range of regulatory documents including labeling, packaging, IFUs, EC/IRB Correspondence, Product Dossiers, and SmPCs. When devices are ready to be sold in foreign markets, we localize accurate and culturally appropriate marketing materials, websites, eIFUs and eLearning modules. To round out the product lifecycle, we provide translations for adverse event reporting.
Morningside utilizes industry-leading technology to help lower costs, improve quality and enhance your customer experience. Translation memory (TM) tools, for example, allow us to leverage previously translated segments to speed up delivery, ensure consistency and ultimately save on translation costs. We also make it easy for you to manage your projects through secure ISO 27001:2013-backed platforms. You can get quotes, submit new projects, and download deliverables via our Life Science Platform and review and edit completed translations through our In-Country Review Platform.