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—
Get Your Free 510(k) Template for FDA Compliance!
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company
Why Partner with Freyr?
![On-Time Submissions]( "On-Time Submissions")
Accelerated Submission Process:
Reduce the time to market for your device with our efficient submission approach
![Proven Track Record]( "Proven Track Record")
Expert Guidance Throughout:
Receive clear, detailed support at each stage of the device lifecycle to ensure compliance
![End-to-End Solutions]( "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]( "Trusted Local Expertise")
Tailored Consulting Services:
Customized consulting to meet your specific needs and address challenges in the submission process
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.
