Hansem Global and Amin Wasserman Gurnani Announce Strategic Collaboration to Support U.S. Medical Device Market Entry

Irvine. California / 500NewsWire / November 3, 2025 / Hansem Global, a leader in multilingual technical documentation, announced a strategic alliance with renowned U.S. law firm Amin Wasserman Gurnani (AWG) to help medical device manufacturers enter the highly regulated and hypercompetitive U.S. market.

The collaboration combines AWG’s FDA regulatory expertise with Hansem Global’s multilingual instructions for use (IFU) documentation services, and was created to offer a single, coordinated plan for medical device manufacturers to achieve U.S. market access.

Under the collaboration, AWG will advise clients on FDA product classification, marketing submissions (including 510(k), De Novo, and Premarket Approval (PMA)), and labeling and advertising compliance, as well as other FDA pre- and post-market compliance issues. Hansem Global will develop IFU and technical documents that meet both FDA requirements and international standards, such as 21 C.F.R. Part 801, ISO 20417, and ISO 15223-1.

“FDA compliance and clear, multilingual documentation are critical for U.S. success,” said Yangsook Kim, CEO of Hansem Global. “Our collaboration with AWG enables manufacturers to address both challenges in one step, reducing risk and accelerating time to market.”

“Medical device manufacturers face a dynamic and complex regulatory environment in the U.S.,” said Neil O’Flaherty, Head of AWG’s Medical Device Industry Practice Group. “Through our joint assistance efforts with Hansem Global, we look forward to helping medical device firms better understand the FDA device regulatory framework, gain U.S. market entrance, and establish best practices for maintaining regulatory compliance.”

About Hansem Global

Hansem Global provides multilingual translation and technical documentation services for global manufacturers. The company specializes in FDA-compliant IFU development and international standard documentation.

About Amin Wasserman Gurnani

One of the country’s leading regulatory, intellectual property, and litigation boutique law firms, Amin Wasserman Gurnani focuses on the medical device, food and beverage, nutritional supplement, OTC drug, cosmetic, and pet health industries, providing complete legal services for the lifecycle of products aimed at improving the population’s health and wellness. The firm has offices in Chicago, Washington, DC, and Los Angeles.

Media Contacts:

Hansem Global – Brian Cho

Email: [email protected]

Amin Wasserman Gurnani – Neil O’Flaherty

Email: [email protected]