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Translation & Localization

Entering the U.S. Medical Device Market: IFU and FDA Compliance in One Step

For medical device manufacturers entering the U.S. market, product performance alone is not enough. To succeed, companies must navigate FDA regulatory requirements, determine the correct product classification, obtain premarket clearance or approval in many cases, and prepare compliant labeling and advertising. Equally critical is the development of Instructions for Use (IFU) documents that meet international standards as part of labeling preparation.

To support this dual requirement, Hansem Global and Amin Wasserman Gurnani (AWG) have formed a strategic alliance to provide a comprehensive solution for manufacturers entering the hypercompetitive U.S. market: AWG helps clients develop legal and regulatory compliance strategies, while Hansem Global delivers multilingual IFU and technical documentation.

AWG: Strategic Regulatory Guidance for the Entire Product Lifecycle

From product inception to market entry and post-market risk management, AWG guides clients through the complex regulatory framework of the U.S. medical device industry. The firm’s services include:

  1. Product Classification and Regulatory Scope
    • Determining whether a product falls under FDA regulation as a medical device or under the Consumer Product Safety Commission (CPSC) or some other federal agency
    • Advising on how wording or design can shift a product’s regulatory status
  2. FDA Marketing Strategy
    • Assessing whether a product requires:
      • Premarket Notification (510(k))
      • De Novo Classification Request
      • Premarket Approval (PMA)
      • or Qualifies for Exemption
    • Developing the optimal route to market and managing the marketing authorization  process
  3. Post-Market Compliance Support
    • Facility registration, product listing, quality system compliance (GMP), adverse event reporting (MDR), and FDA inspections
    • Labeling and advertising compliance, for prescription and over-the-counter devices
  4. Risk Management and Legal Defense
    • Responding to FDA Warning Letters, product recalls, class action lawsuits, and patent infringement claims
  5. Interdisciplinary Expertise
    • AWG’s attorneys include former FDA and government officials and dedicated industry experts
    • The firm’s team brings expertise in various science and engineering disciplines
    • AWG delivers not only legal guidance, but also business-aware, operationally grounded solutions

Hansem Global: IFU Expertise that Supports Regulatory Success

Even with FDA marketing authorization, your product cannot reach the market without IFU documentation that meets both U.S. and international requirements. Hansem Global has decades of experience producing multilingual IFUs that meet both international standards and FDA regulatory requirements.

We specialize in:

  • Structuring information clearly for end users
  • Designing visual aids and layout for maximum readability
  • Ensuring consistency across languages and product variants
  • Interpreting and applying applicable regulations and standards—such as 21 C.F.R. Part 801, ISO 20417, and ISO 15223-1—to ensure regulatory compliance and audit-readiness

Where AWG maps the regulatory path, Hansem Global turns that strategy into documentation that speaks clearly and confidently to users—in English and beyond.

Final Thoughts: Two Essentials for U.S. Market Access

FDA marketing authorization is only the beginning. Without compliant documentation and a strategic approach to FDA regulatory compliance, even well-designed products can face barriers in the U.S. market.

With AWG and Hansem Global as your partners, you can simplify the path to market and ensure your product meets the highest standards—legally and operationally.

Learn more about how we can support your FDA regulatory and documentation needs: