We provide regulatory and clinical support services as requested by our clients. We collaborate with your team to troubleshoot and to achieve cost effective, timely, and evidence-based solutions.

Regulatory Affairs

Safe and effective medical devices are the true endpoints of regulatory requirements.

We have assisted our clients in achieving tremendous success in securing global regulatory approvals for de novo and legacy technologies. We support you on the continuum of your regulatory pathway, from submission to maintenance of post-market compliance.

We understand that the medical device industry is a global market race with ever-changing regulations. The integrity and accuracy of scientific content for your submissions, however, should be a constant. We provide that solid foundation and allow your team to cross the finish line successfully.

Systematic and robust literature searches, comprehensive adverse event database analyses, and Clinical Evaluation Reports are our specialties. We are currently helping clients to make the transition from the MDD to the new EU MDR requirements and develop compliant post-market strategies. And for US markets, recent emphasis has been to assist clients with new 510(k) submissions and provide the data analysis necessary for clients to cross the PMA finish line.