“Navigating the complexities of the 510(k) process for the first time can be daunting, especially with a novel technology like ours. However, Acertara’s expertise and guidance made all the difference. Their support was a source of relief for us, knowing that we had a knowledgeable and experienced team to guide us. From the initial stages of the submission to the final clearance, they were with us every step of the way. I wholeheartedly recommend Acertara to any organization needing expert regulatory consulting services, particularly those new to the 510(k) submission process. Their professionalism, attention to detail, and commitment to their clients are truly commendable.”

Christopher Schlenger
CEO/President
Verdure Imaging, Inc.

“I wanted to extend our tremendous gratitude for all of your support in helping our project team achieve this milestone! Not only did you offer your technical and regulatory expertise, but your anecdotes and insights also helped my sanity along the way.”

Ryan Yamane
Staff Engineer
Research and Development

“Our experience working with the regulatory experts at Acertara far exceeded our expectations. The Acertara team developed a robust submission strategy and was able to greatly simplify the 510(k) process. As it turns out, we obtained 510(k) clearance for our product prior to the actual completion of the product design and development. This clearance removed a potential barrier for the commercialization of our product once it is ready to be shipped to customers. We would highly recommend Acertara, not only for their superior engineering and testing services, but also for regulatory expertise.”

Frank William Mauldin, Jr Ph.D.
Chief Technology Officer
Rivanna Medical, LLC

“I just told another Director and Imaging Specialist about the great service I received. I needed something done, and it is getting done. This was efficient, courteous and dare I say a pleasant experience. We will be pleased to continue utilizing you for all our ultrasound probe needs at Palm Coast.”

Anthony Pierri
Director
Crothall/Advent Health

“I really appreciate your transparency with me! It communicates to me that you’re a reputable company that’s trying to improve and be your best for your customers.”

Keith Glass
Diagnostic Imaging Service Engineer
Spectrum Health

“You guys are hands down the best contractors/consultants I have ever dealt with.”

Chris Valentine
Principal R&D Engineer
New Platforms R&D

“Acertara acoustic laboratories is an ISO17025:2017 test lab. It is accredited to conduct IEC6061-2-37 disagnostic ultrasound test measurements for all medical devices. I would testify to the professional effort and all-around help extended to us by the team at Acertara. “Regulatory Experts” to say the least! – all of our 510(k) questions have been answered and all of our testing is completed. Simply, an EXCELLENT JOB, simply an EXCELLENT COMPANY!”

Anthony J. Martini
Principal Engineer
Terumo Heart, Inc.