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Electronic Product Information (ePIs) are digital versions of paper product information and documentation relating to medical devices, pharmaceuticals, and other healthcare-related products. They’re designed to provide healthcare professionals, patients, and consumers with accessible, up-to-date, and comprehensive information on the use, safety, and efficacy of products. With 24 official languages in the EU, translating and localizing […]

For life sciences companies, accuracy is always the highest priority. Mistakes or misunderstandings can have significant consequences, so translations need to be done right the first time. But how do you know if your translations are accurate? This is where independent quality checks come into play. Conducted by specialized third-party vendors, this quality step ensures […]

The European Union’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) have brought about significant changes to clinical investigations of the devices that they regulate. In the context of the European Union Medical Device Regulation (EU MDR, Regulation (EU) 2017/745), “clinical investigations” refer to systematic studies conducted on human subjects to assess […]

Patient-centered care is a core principle in modern healthcare. In the most basic terms, patient-centered care emphasizes that healthcare should be tailored to each patient’s unique needs, preferences, values, and circumstances. This approach has been shown to significantly improve healthcare outcomes, creating environments where patients feel valued, understood, and are more engaged in their care. […]

In today’s international business landscape, the ability to communicate clearly and comply with local regulations is not just beneficial—it’s essential to doing business in the first place. Globalization offers businesses unprecedented opportunities to expand their reach across borders, tapping into new markets and consumer bases. However, these types of opportunities require navigating complex local laws, […]

Consisting of Iceland, Liechtenstein, Norway, and Switzerland, the European Free Trade Association (EFTA) is a regional trade association that plays a key role in shaping trade dynamics, particularly within the European Union (EU). Despite not being EU members, EFTA countries align their regulations closely with the EU to ensure seamless trade and regulatory cooperation. This […]

Japan is widely acknowledged for its technological prowess, yet strategies and platforms that prove highly effective in Western markets can often be met with suspicion by Japanese consumers, due to the culture of formality and propriety. In this blog post, Akagi Kobayashi, a Translation and LQA professional, shares the key points to consider before engaging […]