Regulatory Affairs
510(k) Submissions
We prepare and submit 510(k) applications to demonstrate that your device is substantially equivalent to a legally marketed device, ensuring a smooth path to market.
Investigational Device Exemption (IDE)
We assist in obtaining IDE approvals, allowing you to conduct clinical studies with your medical device to gather the necessary data for regulatory submissions.
Premarket Approval (PMA)
Our team provides comprehensive support for PMA applications, including clinical trial design, data analysis, and submission preparation, to secure FDA approval for high-risk medical devices.
FDA Pre-Submission Meetings
We facilitate pre-submission meetings with the FDA to discuss your device and receive valuable feedback, helping to streamline the approval process.
FDA Feedback or Deficiency Mitigation
We help address any feedback or deficiencies identified by the FDA, ensuring your application meets all regulatory requirements and standards.
Support for Outside the US (OUS) Markets
Our clinical research company streamlines regulatory approvals and affairs for OUS markets like Canada, Medica, the EU, and MDR regions. We ensure compliance and accelerate your time to market