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Comprehensive FDA Compliance Services
- 510(k) Filing (Traditional, Special, Abbreviated)
- De Novo Classification Support
- PMA Submission & Approval
- US Agent Services for FDA-registered establishments
- Quality System Compliance (21 CFR Part 820)
- UDI Labeling Compliance
- 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
Ready to Navigate Complex and FDA medical device product registration with ease?
Success Stories
Freyr Solutions helped a UK-based company overcome Regulatory hurdles by filling in missing data and clarifying predicates for fast-track 510(k) approval, ensuring complete FDA company registration and compliance.
Frequently Asked Questions
A 510(k) is required for devices with a legally marketed predicate. This process demonstrates that your device is as safe and effective as an existing FDA-registered medical device on the market.
- 510(k): For devices similar to existing ones on the market (moderate risk).
- De Novo: For novel devices without a predicate (moderate to low risk).
- PMA: Required for high-risk devices where extensive safety and efficacy data is necessary.
The duration varies depending on the pathway chosen. A 510(k) submission typically takes 90-120 days, while a PMA process can take 180 days or longer. Freyr Solutions ensures a faster and more efficient process through meticulous preparation and support for FDA establishment registration.
You'll need details such as:
- Device classification and intended use
- Design, performance, and safety data
- Clinical evidence (if applicable)
- Labeling and packaging information
Freyr assists in seamlessly compiling and managing these elements to ensure you're a fully FDA-registered manufacturer.
The FDA requires foreign manufacturers to appoint a US Agent to manage communication and ensure Regulatory compliance. Freyr's proven expertise as a trusted US FDA-registered establishment agent simplifies your engagement with the FDA.
Absolutely. Freyr provides complete post-market surveillance, labeling updates, audit readiness support, and compliance monitoring for FDA-registered sites.
Freyr accelerates approvals by:
- Identifying the correct submission pathway
- Conducting a detailed gap analysis of technical documents
- Providing pre-submission strategies and Regulatory meetings with the FDA
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.
