,A Proven Track Record
Freyr has successfully helped various multinational device manufacturers across the globe get 510(k) approvals
We provide Successful Regulatory Strategy for guiding the product registration process
We achieve 100% Quality Compliance of technical documents required for 510(k)
We ensure Timely Compilationand Submission of 510(k) with minimum queries from the US FDA
Freyr 510 (k) Competencies
- Comprehensive US FDA Regulatory and Submission Strategy
- Identification of Predicate Device for Substantial Equivalence Analysis
- Identification of Applicable Standards
- Gap Analysis as per US FDA regulation and international standards
- Compilation of all sections of 510(k) Technical File in eSTAR format
- Publishing of eSTAR template
- Addressal of review deficiencies and AINN response
- Liaising services for Device Clearance
- Consultation services for addressing deficiencies
- Establishment Registration
- Device Listing & FURLS data base maintenance
- Device Lifecycle Management
Experience hassle-free and assured 510(k) approvals with Freyr
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 Choose Freyr?
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Regulatory Expertise
Dedicated 510(k) experts ensuring seamless approval of the 510(k) pathways
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Faster Approvals
Proven strategies to expedite 510(k) submissions, reducing time-to-market
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Customized Solutions
Tailored services for your specific device and needs for successful FDA 510(k) clearance
![Accelerate your 510 (k) Approval Process]( "Accelerate your 510 (k) Approval Process")
Risk Mitigation
We ensure your submission meets FDA requirements, minimizing compliance risks
Frequently Asked Questions (FAQs)
In order to submit a 510(k) using the FDA's eSTAR pilot program, you will have to download and complete the eSTAR template from the FDA's website, ensuring all required information and attachments are included. Validate the submission using the template's built-in tool, then submit the final PDF through the FDA's Electronic Submissions Gateway (ESG).
Before initiating it’s advisable to confirm that your device and submission are eligible for the eSTAR program. You can check via guidelines available or through a 510 (k) consultant.
In certain cases, the FDA has classified specific medical devices as "exempt” which means that the medical device is not required to undergo the usual 510(k) submission process to obtain FDA clearance. For instance, low-risk devices with well-established safety profiles and minimal risks to patients may qualify for this exemption.
However, 510(k) exempt devices still have to comply with certain regulatory norms specified by FDA.
Yes, a Quality Management System (QMS) is typically required for a 510(k) submission. The manufacturers going for 510(k) has to follow Quality System Regulation (QSR) (21 CFR part 820).
