Product Registration in the USA
The U.S. medical device market is one of the most regulated and competitive in the world. For a product to be marketed in the United States, it must rigorously comply with the requirements of the Food and Drug Administration (FDA). Our consulting service was developed to support companies at every stage of the registration process, ensuring regulatory compliance and rapid market entry.
What do we offer?
Initial Regulatory Assessment
Identifying the device classification and defining the submission strategy (510(k), De Novo, or PMA).
FDA Company Registration and Device Listing
We handle the annual registration of your company and the inclusion of your device in the FDA systems to ensure you are in full compliance.
Response to FDA Form 483 and Warning Letter Remediation
We developed 483 responses and corrective action plans to address the FDA's observations and complete the warning letters.
Preparation of Technical Documentation
Support in the preparation of dossiers, test reports, clinical validations, and evidence of safety and efficacy.
Implementation of the UDI System and Submission to the GUDID Database
We assist in the implementation of UDI and submit device identifiers to the FDA's GUDID database to meet traceability requirements.
Post-Marketing Surveillance and Adverse Event Reporting (MDR/CMDR)
We implement PMS systems and manage MDR/CMDR reports to ensure your compliance after market entry.
FDA Premarket Notification 510(k)
We prepare complete 510(k) submissions, identify reference devices, and manage interactions with the FDA through to approval.
Quality Management System (QMS) —
(ISO 13485 and QMSR)
We develop and audit QMS (Quality Management System) documentation to meet the requirements of ISO 13485 and the QMSR (FDA Quality Management Regulation), supporting your certification process.
Training and Capacity Building
We provide training for internal teams on regulatory best practices and maintaining post-registration compliance.