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.
EU MDR Summary of Safety and Clinical Performance (SSCP) requirement: smart practices for multilingual compliance
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[...]
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[...]
International studies run by CROs are essential to the pharmaceutical industry, but the high level of regulation required by multiple governing bodies makes running a clinical trial a complex undertaking.
Life science translation comprises medical documentation related to medicines and medico-technical equipment that at a minimum can improve the quality of life for many people worldwide, and that ultimately can save human lives.
When it comes to pharmaceutical translations, some specific factors need to be considered, one of which is the target audience.