Medical device expertise from concept through FDA approval
Biomedical Consulting
30 years experience in the biomedical industry to serve you.
We will tailor our services to your very unique and specific needs to accelerate your FDA approval and market introduction. Our goal is to assist you in being successful for the short and long terms:
Guide your global clinical and regulatory strategy
Help you prepare successful submissions for the FDA (QSub, IDE, 510k, PMA, 513g, RFD, responses to deficiencies etc.)
Provide you with the tools to continue grow
“YDE Biomed Consulting is my “go-to” resource for FDA submissions, clinical study submissions and reporting and in preparing everything necessary to get FDA approval for my combination device. The team at YDE Biomed Consulting has decades of regulatory, quality and medical device operations knowledge. They interface with FDA on an ongoing basis and are up to the state of the art for compliance and success of FDA regulatory submissions.”
Morris - Chief Compliance Officer - Dental Device company, USA
“Catherine played a pivotal role for the FDA 510(k) application of our Software as a Medical Device. She expertly outlined each required step and provided invaluable guidance on compiling the essential documentation. Her expertise ensured the successful outcome of our applications, and we would work with her again.”
Guillaume - Chief Strategy Officer - Cardiac Simulation & Imaging Software Company, Europe/USA
“Catherine has provided invaluable leadership and guidance to our company for a number of complex, and successful, projects in both the device and pharma areas. Catherine is an exceptionally clear thinker, basing her advice/guidance on a well-researched, fact-based approach. Her support of our company has been deeply appreciated.”
Tom - Vice-President, Regulatory Affairs & Quality - Dental Products company, USA
