Device Regulatory

Device Regulatory Success Stories

“The expertise available at the FDA Group is fantastic. We had an issue that necessitated a specific FDA experiential background and knowledge of the most appropriate path to an successful resolution, and the FDA Group was able to provide a highly proficient consultant to address our needs. They were able to act quickly and decisively, and at cost a small medical device company could afford. I will not hesitate to use the FDA Group services as our needs arise and would highly recommend the FDA Group services to any company requiring assistance on regulatory compliance topics.” 

"We are a medical device/health tech start-up. We worked for two years with another regulatory consulting firm only to find ourselves frustrated and unable to convince the FDA that our device was substantially equivalent to our Class II predicate. Within weeks of being introduced to The FDA Group, we had an entirely new approach to the FDA. Our consultant helped us take a step back and re-evaluate the landscape of competitive devices. We jointly developed a path to Class I compliance...allowing us to get into the market and begin generating revenue. An improved version of our device will be submitted for Class II clearance but only after careful dialogue with the FDA in a pre-sub process—not something we did the first time around. Bottom line—we are truly grateful to have found The FDA Group."

“To all who are considering doing business with The FDA Group, we would recommend them with no hesitation. The FDA Group is very professional and does business promptly. They responded to us at all hours of the day or night if we were trying to resolve a situation and move ahead. We know you will be satisfied with the project done for you.”

“As a small start-up class II medical device company, we were in need of expertise and assistance in navigating the FDA 510(k) submission process. We were fortunate enough to contract with The FDA Group, LLC for these services. Our highly personable account manager was exceptional on assessing our needs and assigning the appropriate consultant. Our assigned consultant was professional, knowledgeable, accessible and with top-of-the-class practical advice and guidance on what we needed to do for the 510(k) submission. Looking back at our experience, we could not have asked for better service and results from The FDA Group, LLC.”

“I highly recommend contacting The FDA Group, LLC if your company is in need of regulatory consulting. They have successfully matched the right consultant to the right issue for our business many times. From day-to-day Regulatory Affairs questions and training to significant issues such as recall management and 483 responses, The FDA Group has a pool of consultants to pull from that can assist you both expeditiously and professionally.”

“I wanted to let you know how impressed we are with The FDA Group. Your knowledge, thoroughness, and ability to work with our staff was very impressive. You were extremely informative and well received by our all of our staff. We really appreciate your effort to coordinate the visit. This is the type of interaction that builds a strong relationship and your organization is on the top of our referral list. We look forward to the report as well as a continued relationship with The FDA Group.”

“The FDA Group was extremely helpful when I needed some guidance about my medical device. They provided excellent insight and were able to gather information that allowed my product to avoid testing – a savings of thousands of dollars. I would highly recommend the FDA Group.”

“The three of the folks who performed our work did a fantastic job and did what was asked of them. In fact, they did a bit more then what was required which will ultimately help the site in the long run. The site does appreciate their efforts. I would recommend them again for this type of work or something similar.”