Applying a centralized translation process is a proven strategy to save on translation costs and turnaround time, reduce regulatory risks, and more importantly, improve content quality, and consistency across languages.
EU MDR Summary of Safety and Clinical Performance (SSCP) requirement: smart practices for multilingual compliance
We’re all aware of the impact EU Medical Device Regulation (MDR) has on product labeling, as many Medical Device companies have prepared their multilingual product documentation and labeling for compliance.
Life science translation comprises medical documentation related to pharmaceutical products, medical devices and other health technologies that, at a minimum, can improve the quality of life for many people worldwide, and that ultimately can save human lives.
The MedTech market is expected to be worth USD 613 billion by 2025. As the value of the market grows, so does the volume and complexity of the associated regulated information that needs to be managed.
High-risk and labor-intensive processes are usually the low-hanging fruit for process and technical innovation. Creating and managing updates to global life sciences product labeling falls well within this category, providing plenty of scope for improvement.
With the new EU Clinical Trial Regulation (No. 536/2014) going into effect starting January 2022, Clinical Operations teams within Sponsor and CRO companies should make sure that language service providers are ready to handle the impact of the new regulation. It establishes a Clinical Trials[...]
As the MDR deadline approaches, many Medical Device companies have updated their multilingual product documentation and labeling to be ready. However, compliance isn't done by simply updating product content before the deadline. The new regulation’s focus on post-market surveillance (PMS), product[...]
With the MDR deadline approaching in May 2021, most medical device companies are well on their way to getting ready. Here at Acolad, we've been busy with over 250 of our medical device clients, providing medical translations in all EU languages for the MDR requirements.
According to data from the European Union, there are over 500,000 different medical devices on the EU market. This could include anything from contact lenses to a hip replacement, or even bandages.
Medical device companies creating product labeling and quality documentation with MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating IFUs, operating manuals, quality reports and technical[...]