President & CEO
Rocky Mountain Regulatory and Quality Partners
John Van Hoven is the President, CEO, and principal consultant at Rocky Mountain Regulatory and Quality Partners, a quality assurance and regulatory affairs firm based in Utah. With over 16 years of experience as a researcher and regulatory consultant, John has helped successfully deliver numerous types of medical devices to market, thanks to his ability to prepare his clients for the regulatory process, navigate various complex bureaucratic systems and ensure compliance at every step of the process.
Combining his experience as a researcher and regulatory affairs and quality assurance consultant, John brings a unique skill set to his clients. He has worked with regulatory bodies such as the FDA, EU Competent Authorities, Notified Bodies, Authorized Representatives, and Health Canada, aiding in preparing submissions for a wide scope of medical device companies, both small and large. His research experience allows him to understand the development process of medical devices, while his regulatory affairs experience allows him to prepare successful submissions. John has conducted numerous Regulation (EU) 2017/745 (MDR) deep dive gap analysis work on technical files for Class I, IIa, IIb and III files.
Tuesday, October 27, 2020
13:30 – 14:30 CET