Regulatory
510k Process
Our consultants have over 100-years of FDA regulatory and sales/marketing backgrounds and business ownership. They understand not only the regulatory side of your submission but also the marketing side. They understand the financial pressures placed on all businesses when trying to comply with FDA regulatory requirements and the costs of having to perform expensive testing in order to demonstrate the safety and effectiveness of your device compared to that of your chosen predicate . At the end of the 510k process, it is important to ensure your cleared marketing claims provide your salesforce or distributors the necessary sales claims to be competitive and compliant with all governmental regulations.
We have had over 280 successful 510(k) clearances across all CDRH reviewing Branches.
Product Classification
Establishment and Device Registration
We have been serving the Medical Device Industry since 1994 assisting companies large and small in receiving Food and Drug Administration clearance for new devices.
We have a proven track record of assisting manufacturers with their regulatory compliance issues. As the United States Agent for your company, we can ensure compliance with all regulations.
Additional US Agent Services
Complaint Handling and eMDR Submissions
Complaint Handling
eMDR- Electronic Submission of MDR
(Medical Device Reporting)
As part of our US Agent service, we can assist the low-volume MDR submitter by electronically submitting your MDRs through our gateway portal. This service is helpful for the international client with an infrequent need to submit a medical device report to the FDA.