Hansem Global: Your Global Partner in Pharmaceuticals, Biotech, and Healthcare

2026.11.06

The pharmaceuticals, biotechnology, and healthcare industries in Korea hold significant growth potential in the global market. Many companies are expanding into international markets, leveraging Korea’s capabilities in biopharmaceutical research and development. However, effective communication strategies and precise translations are essential for success. Particularly in the pharmaceuticals, biotechnology, and healthcare sectors, where specialized documents are abundant and regulations are complex, accurate and effective translation is crucial.

The Vital Role of Back Translation in Safeguarding Patient Safety: A Deep Dive into Translating “Instructions for Use” in Medical Devices

2026.11.06

In the complex landscape of medical devices, ensuring clear and accurate communication is not just a matter of convenience; it’s a critical component of patient safety and regulatory compliance. “Instructions for Use” (IFU) serve as the cornerstone of guidance for healthcare professionals and patients navigating the intricacies of device operation and maintenance. However, translating IFU presents formidable challenges, demanding meticulous attention to detail and precision to avoid potentially dire consequences. In this comprehensive exploration, we delve into the indispensable role of the back translation process in upholding the integrity and accuracy of translated IFU for medical devices.

Medical Device IFU & Labeling for US Market Entry (FDA 510(k))

2026.10.30

For a medical device, the manual itself can hold up market entry. In regulatory terms the user manual is the IFU (Instructions for Use) – a core document tied directly to product clearance, labeling, and usability evaluation, and one of the most common reasons an FDA 510(k) submission stalls. This second installment of our Manuals Under Regulatory Scrutiny series maps the IFU and labeling requirements that medical device manufacturers most often run into when pursuing FDA 510(k), Health Canada, and MDSAP, and explains why regulatory strategy and document production must be managed together.

What Information Does the FDA Expect in Your IFU?

2026.10.30

A Practical Guide to Preparing Instructions for Use (IFU) for U.S. Medical Device Marketing Authorization

FDA Medical Device Webinar: IFU and Labeling

2026.10.23

Hansem Global is co-hosting a webinar with Amin Wasserman Gurnani (AWG), a U.S.-based FDA regulatory law firm, on what it takes to bring a medical device to the U.S. market. “How to Get It Right: Legally Launching a Medical Device in the U.S.” brings legal…