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.
2026.10.30
A Practical Guide to Preparing Instructions for Use (IFU) for U.S. Medical Device Marketing Authorization
2026.10.23
The U.S. remains one of the most competitive and tightly regulated markets for medical devices. But even with a high-quality product, many companies face costly delays—not because of flaws in technology, but due to gaps in documentation or misunderstanding of regulatory requirements.
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…
2026.03.18
The debate around machine translation vs AI translation is getting louder every year. With the rapid rise of AI in translation, it sometimes feels like the industry is standing at a crossroads. Is traditional machine translation becoming outdated? Is generative AI the new standard? And…
2025.12.29
As the year draws to a close, Hansem Vietnam marked one of the most meaningful milestones in its journey: Freelancer Day 2025, an event that was not only bigger in scale, but deeper in purpose. Scripted by Nhung Nguyen This year’s celebration was especially significant…
2025.12.19
Artificial intelligence is transforming every corner of the workplace— and content workflows are no exception. While manufacturers often focus on AI’s role in production or logistics, a quieter but equally impactful shift is underway in how product-related content is created, translated, and reviewed. Scripted by…
2025.12.17
Ten years – A decade of teamwork, late nights, laughter, and growth. From our very first project back in October 2015 to those late-night simulations that stretched past midnight. From the months of working from home during the pandemic to the countless lessons we’ve learned…
2025.12.12
Not long ago, freelance translators worked quietly behind the scenes. Files arrived by email, and once the translated document was submitted, their role ended—often without the client even knowing who translated their content. But today, everything has changed. In the era of cloud-based translation platforms,…
2025.12.05
As products become more complex and the number of localized languages increases, managing documentation quality—especially for user manuals and technical documents—has become significantly more challenging. Manual quality checks often fail to catch recurring issues, and under tight deadlines, even minor oversights can result in costly…
