FDA regulatory consulting for medical devices
Legal background
The U.S. medical device regulatory framework is constantly evolving, with frequent updates to FDA compliance guidelines, submission requirements, and enforcement priorities. Misinterpreting or overlooking these regulations including FDA labeling requirements for medical devices and mandatory registration of medical devices can lead to costly delays, product refusals, or enforcement actions.
Accurate listing ensures:
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- Avoid non-compliance, refusals, and enforcement actions
- Keep pace with regulatory changes and FDA updates
- Minimize time to market for your medical device
- Ensure smooth submissions and renewals
- Maintain long-term market presence with confidence
Our services
How Obelis Supports Your FDA Compliance Journey
As your appointed U.S. Agent or a dedicated FDA regulatory consultancy agreement, Obelis provides tailored support for all stages of your FDA compliance journey. You will receive regulatory information and alerts to keep you up to date with new FDA requirements, including FDA requirements for medical device labelling and updates to the FDA’s clinical decision support framework. We represent you before the FDA (if appointed as U.S. Agent), keep you informed with timely regulatory alerts, assist with complex submissions like 510(k) or De Novo applications, and offer ad hoc guidance aligned with your business goals. With Obelis, you gain a proactive partner who helps simplify your regulatory responsibilities and mitigate compliance risks.
