The EU Clinical Trial Regulation (EU CTR 536/2014) is a comprehensive framework designed to enhance the safety, transparency, and efficiency of clinical trials conducted across the European Union. A key aspect of this regulation is its emphasis on clear, accurate...
For medical device manufacturers aiming to access the European market, complying with evolving regulations is essential to ensure patient safety, maintain quality standards, and stay competitive. With growing demands for transparency and patient safety, the European...
The medical device industry is a fast-growing, highly regulated sector that serves patients and healthcare providers worldwide. With a market valued at over $500 billion in 2024, the global market is expected to grow at a compound annual growth rate (CAGR) of around...
Introduction: The Critical Role of Translation in Healthcare In today's globalized healthcare environment, accurate medical translation directly impacts patient safety outcomes. Clear communication across languages ensures proper medication administration, informed...
Ever had that sinking feeling when months of hard work hit a roadblock? That's exactly what happens when companies hear: "Your FDA submission is on hold due to translation issues." We've seen it firsthand. A promising medical device, a breakthrough drug, or an...
In the medical device industry, compliance with international standards is not just a legal obligation—it’s a strategic necessity that safeguards quality, patient safety, and global market access. ISO 13485 is the international standard for Quality Management Systems...
In today’s digital age, electronic Instructions for Use (eIFU) play a vital role in the medical device industry. These digital versions of traditional paper IFUs allow manufacturers to provide real-time updates, improve accessibility, and comply with various global...
As the demand for multilingual clinical trials grows, so does the importance of accurate, culturally adapted translations. With clinical trials often spanning across multiple countries and involving participants from all over the world, medical translation is now the...
Clinical trials are research-oriented studies conducted with human participants to evaluate the safety, efficacy, and potential side effects of new medical treatments, drugs, vaccines, or medical devices. These trials are essential in advancing medical science by...