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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 […]

Engaging in business in Japan presents both opportunities and challenges, as each solved obstacle enhances the potential for business expansion. To navigate the complexities of the Japanese market, we invited an expert in translation and LQA, Akagi Kobayashi, to share her key strategies for successful localization in Japan. The importance of “Beautiful Japanese” For Akagi, […]

Mastering Japanese LQA presents a formidable challenge due to the intricacies of both the language and culture. However, for those who can overcome these challenges, the potential for business success is immense. Consider the following key factors:  Japan stands as the world’s third-largest economy, boasting a diligent and highly educated workforce.  With a population of […]