Ensure Seamless FDA Compliance with a Trusted U.S. Agent

If your medical device company is located outside the United States and launching a medical device in the United States, a designated U.S. Agent is required to facilitate communication with the FDA. MAK & Associates provides reliable, professional FDA U.S. Agent services to help global medical device manufacturers meet regulatory requirements and streamline their market entry into the U.S.

Our FDA U.S. Agent Services Include:

✅ Official U.S. FDA Representation

  • Act as your official FDA-designated U.S. Agent for regulatory compliance.
  • Serve as the primary point of contact between your company and the FDA.

✅ Regulatory Communication & Liaison

  • Receive and respond to FDA inquiries, including inspections, audits, and compliance notices.
  • Facilitate communication regarding registration, adverse event reporting, and enforcement actions.
  • Notify you promptly of any FDA correspondence and provide guidance on necessary actions.

✅ Medical Device Establishment Registration Support

  • Assist with FDA Establishment Registration and Device Listing compliance.
  • Ensure proper submission of regulatory documentation.

✅ Pre-Market & Post-Market Compliance Assistance

  • Support with 510(k), PMA, De Novo, and Q-Submission processes.
  • Provide guidance on post-market surveillance (PMS) and adverse event reporting.
  • Help ensure compliance with U.S. medical device regulations and ongoing requirements.

✅ Emergency Contact & Regulatory Support

  • Available to communicate with the FDA in case of urgent regulatory issues.
  • Offer compliance advisory services to prevent delays and regulatory setbacks.

Why Choose MAK & Associates as Your FDA U.S. Agent?

✔ Expertise in FDA Regulations – Over 30 years of experience in medical device regulatory compliance.
✔ Reliable & Responsive – Prompt handling of all FDA communications to keep your business compliant.
✔ Tailored for Global Companies – Specialized support for international manufacturers entering the U.S. market.
✔ Full-Service Regulatory Partner – Beyond U.S. Agent services, we provide end-to-end regulatory consulting.

Get Started Today!

Ensure smooth FDA compliance and secure your U.S. market entry with MAK & Associates, LLC as your trusted FDA U.S. Agent.

📩 Contact us today to learn more or schedule a consultation!