Simplify FDA Medical Device Compliance with Obelis
Our End-to-End Services
Obelis guides your medical devices to global markets with full compliance, every step of the way.
US FDA Agent Services
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www.obelis.net
Client Success Stories
I encourage companies to seek compliance before putting their products on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.​
 We successfully launched our products into multiple European countries.
Ran Amos
VP of Quality Assurance & Regulatory Affairs
We were under huge time and cost pressure for a new OEM product line launch and we relied on Obelis. It was the right decision, their expert team helped us to avoid possible regulatory complications.
Their expert team helped us to avoid possible regulatory complications
Florian L. GablenzÂ
Business Development ManagerÂ
We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make it seem so easy.
 We feel very supported!
Javier Aravena
Regulatory Affairs Manager
FDA Communication
We handle all correspondence with the FDA on your behalf
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Response Preparation
Expert preparation of responses to FDA inquiries
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Inspection Support
Coordination and support during FDA inspections
At Obelis Group, we act as your Official U.S. FDA Agent & Correspondent, guiding you through every step of the process. From strategic planning to full regulatory compliance, we simplify compliance for medical device manufacturers worldwide.
Your official representative for all FDA communications
Appoint Obelis as your US AgentÂ
Official Correspondent
FURLS Management
Complete management of your FDA registration system
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Annual Renewals
Timely handling of all annual registration requirements
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Primary Contact
Official FDA communication point for your company
Your primary point of contact for all FDA regulatory matters
Obelis as your Official CorrespondentÂ
Initial Consultation
We assess your device and regulatory pathway requirements
Documentation Preparation
Our experts compile and prepare all required regulatory documents
FDA Submission
We submit your application through official channels
Review Process
We manage all FDA communications during the review period
Approval & Maintenance
Post-approval support and ongoing regulatory compliance
Our FDA Submission Process
Streamlined approach to regulatory submissions with expert guidance at every step
Start your compliance journey with Obelis
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Contact our regulatory experts today for a consultation about your medical device requirements.
- 24-Hour Response Guarantee. Get fast support from our regulatory experts.
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- Free Initial Consultation. Speak with an FDA specialist at no cost.
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- Global Market Entry Support. Guidance not only for the U.S. FDA, but also EU, UK, Swiss, and more.
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- Reduced Time to Market. Optimized submission strategies to help you launch faster.
