Semih Oktay is the President and founder of CardioMed Device Consultants.
Ms. Boyle is the Director for Clinical Trial Services at CardioMed Device Consultants.
Ms. Advani is a Principal Consultant with CardioMed Device Consultants.
Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants.
Thanks for all your help and advice provided over the past six years. Your high level of professionalism together with your spread network of experts and extremely good connections at the FDA are the reasons for choosing to work with you. Your service has been valuable help to us at Medinol.
We are an Indian medical device manufacturing company. Cardiomed is associated with us as consultant for regulatory services related to US FDA for our cardiovascular product portfolio. We are extremely happy with their services. We are highly impressed by Cardiomed's knowledge, expertise, and experience in cardiovascular field; not only in regulatory matters but also in other fields like technical aspects of biocompatibility and other testing. They are prompt, result oriented and clear in their approach. Their guidance and support won us first 510(k) clearance for our PTCA catheter. We received their valuable guidance for our stent project which is in progress now. It is a pleasure to work with them.
I had the pleasure of working with Dr. Oktay and CardioMed for the last six plus years with regards to IDE & PMA strategies for Class III vascular implants including coronary and peripheral stents. Areas of guidance included ‘big picture’ strategies on bench-tests and clinical studies as well as specific areas related to bench test methods and synergies with clinical outcomes. Dr. Oktay’s feedback clearly allowed us to have external perspective on regulatory expectations, successfully plan our cadence of submissions based on anticipated product iterations and also supported us to a PMA approval for a key product. I am thankful for having the opportunity to consult and collaborate with Dr. Oktay.