Regulations that govern the life sciences industry are centered around one primary goal: ensuring that medical devices are safe to use. While it can seem challenging to adhere to regional requirements for these devices, following international standards can ensure that medical devices are compliant within various regulatory requirements around the world. These standards help medical […]
Ensuring Quality for Medical Device Translations Read More »
Exponential growth in global markets and the need for quality localization Localization for the life sciences industry is considered a critical component of company success, where precision and clarity of language is vitally important for products and services in the global healthcare marketplace. For medical devices, accuracy in product documentation is even more essential and
Mitigating Internationalization Risks: Life Sciences Industry Read More »
The European Union’s new regulation for in-vitro medical devices, 2017/746 (IVDR), takes effect in May 2022. While IVDR aims to increase patient safety and company transparency, it also creates heightened challenges for the entire supply chain (especially for in-vitro diagnostic companies and their medical safety program managers). In its most recent report, the European Commission
The passing of Brexit in early 2020. The ongoing monitoring of candidate countries. COVID-19. Three formidable challenges have all complicated the race to EU/MDR compliance — as if the regulations weren’t already complicated enough. Ever since the onset of the pandemic, manufacturers worldwide have seen a spike in demand for personal protective equipment (PPE) such
The use of international standards to ensure consistent high-quality goods and services has long been an accepted practice. In a recent blog, we addressed 2 quality management standards: ISO 9001, generally applicable to all industries, and ISO 17100 which is specific to the translation industry. Drilling down into the quality management requirements of one of the
The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. Device manufacturers who market products in the EU must be ready to meet the May 26, 2020 transition deadline. As the deadline nears, you may be realizing that under the new MDR, language and translations play a much more important role in