Market Access

USA-USFDA

Streamline Your FDA Medical Device Registration with Expert Guidance

Navigating the complex regulatory landscape of the U.S. Food and Drug Administration (FDA) can be challenging. Our US Medical Device Registration Consultancy provides end-to-end support, ensuring a smooth and compliant market entry for your medical devices.

Our US Medical Device Registration Roadmap

We offer a structured approach to help you navigate the FDA registration process efficiently.

Device Classification & Regulatory Strategy

  • Determine device classification (Class I, II, or III).
  • Identify applicable regulatory pathways (510(k), PMA, De Novo, or Exempt).
  • Develop a customized submission strategy.

FDA Establishment Registration & Listing

  • Assist in registering your company with the FDA.
  • Ensure proper listing of your medical devices.

Premarket Submission Preparation & Filing

  • Prepare and submit 510(k), PMA, or De Novo applications.
  • Liaise with FDA to address additional information requests.
  • Facilitate responses to regulatory inquiries.

Quality System & Compliance Readiness

  • Ensure compliance with FDA Quality System Regulations (21 CFR Part 820).
  • Implement Good Manufacturing Practices (GMP) and ISO 13485 alignment.
  • Prepare for FDA inspections.

Post-Market Compliance & Support

  • Assistance with FDA audits and inspections.
  • Adverse event reporting and corrections.
  • Compliance monitoring and regulatory updates.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

Links

Services

Contact

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

© Alpine Quality Consultants 2025 | All Rights Reserved

TOP