Testimonials
Theresa G.:
“Robert is the epitome of professionalism, dedication, leadership, and medical device expertise.”
Zachary B.:
“Robert genuinely cares about the patients that receive products and inspires others to maintain a patient-centric approach to their work, thus ensuring the highest quality goes into submissions.”
Gabriela M.:
“Robert has substantial knowledge of the medical device regulatory environment, and his resource should be considered invaluable for any company.”
Jim R.:
“I found Robert to be consistently pleasant, hard-working and dedicated. He authored a number of U.S. and international regulatory submissions for Class III cardiovascular products, including prosthetic heart valves and annuloplasty rings. Robert’s submissions responsibilities included PMA Supplements and Pre-Market Notifications. I highly recommend Robert.”
Audrey S.:
“Robert worked quickly to resolve issues and respond to questions from regulatory authorities. He took pride in producing quality results on time. [His] teamwork approach resulted in accurate and well-constructed output.”
Eugene P., PhD:
“I’ve worked side-by-side with Robert on many projects over the last three years. Much of my research was used to support his regulatory submissions, including 510(k), HUD/HDE, and PMA applications to the FDA as well as Technical Files to support European CE Mark, Canadian device license applications, and market applications in several other countries. With Robert’s assistance, [we] received a PMA approval for a Class III implantable device with a technology and material that were new to orthopedics. Whatever project he was working on, his work was always well organized, concise, and successful. His professional approach was consultative and collaborative, all the while providing leadership in his area of expertise.”
Dan S.:
