Speak to a an expert

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Medical Device Experts to Guide You
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successful 510(k) and 513(g) Filings across Device Categories
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Proven Expertise as a preferred US Agent for 50+ Companies

Freyr’s US FDA Medical Device Compliance Services

  • Establishment registration and Device listing
  • US Agent Services
  • Quality System Regulation (21 CFR 820) Compliance, Transition to upcoming QMSR
  • MDSAP Certification Support
  • QSR compliance for Combination Products (21 CFR Part 4)
  • BIMO Audit Compliance
  • Pre-Market Notification / 510(k) Clearance (Traditional, Special, Abbreviated)
  • De-Novo Classification
  • Pre-Market Approval (PMA) – Original and Supplements
  • Humanitarian Device Exemption (HDE)
  • Investigational Device Exemption (IDE)
  • Pre-RFD and RFD Submission to Office of Combination Products)
  • Q-Submission Meetings with US FDA (Pre-Submission, SIR, Study Risk Determination)
  • 21 CFR 801 – General Labeling Compliance and Device-Specific Compliance
  • UDI Labeling Compliance
  • Small Business Designation (SBD) and CLIA Waiver

Start Your FDA Approval Process Today—

Let’s Get Your Device to Market Faster!

Get Your Free 510(k) Template for FDA Compliance!

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Why Partner with Freyr?

  • On-Time Submissions

    Accelerated Submission Process:

    Reduce the time to market for your device with our efficient submission approach

  • Proven Track Record

    Expert Guidance Throughout:

    Receive clear, detailed support at each stage of the device lifecycle to ensure compliance

  • End-to-End Solutions

    Reduce Costs and Minimize Mistakes:

    Avoid unnecessary expenses and errors with our precise approach to preparing your application

  • Trusted Local Expertise

    Tailored Consulting Services:

    Customized consulting to meet your specific needs and address challenges in the submission process

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Frequently Asked Questions

You’ll need details like your device's classification, intended use, design and performance data, and clinical evidence (if applicable). Freyr helps you in every stage of your device lifecycle – from determining the device classification to technical documentation and post-market surveillance support.

The 510(k) process is generally for devices that have a predicate device and are considered lower to moderate-risk, while the PMA process is for higher-risk devices or those without a predicate. Our dedicated team of FDA experts at Freyr helps you determine the right pathway for your device.

A 513(g) submission is a formal request to the FDA for a determination of the Regulatory classification and requirements for a medical device. It is particularly useful when a manufacturer is uncertain about how a device is classified or whether a specific submission (e.g., 510(k), De Novo, PMA) is required for market entry.

Absolutely! Freyr provides guidance on compliance with 21 CFR Part 820 and the transition to upcoming QMSR requirements.

510 (k) cost can vary based on various factors, the primary being FDA user-free, testing and technical documentation costs, post-market requirements, personnel involved, and Regulatory consultation (if applicable). Since costs can vary widely, it's crucial to consult with experts or industry peers, if possible, to get a more accurate estimate for your specific situation.
 
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