By creating an advisory board with the most forward-thinking minds and pre-eminent talent in the medical device industry, RIMSYS is now aligned and positioned to continue its growth and mission as a regulatory management software provider for the medical device industry.
The board members serve as strategic partners in the continued development and success of RIMSYS, as a catalyst to achieving its short-term and long-term goals. The board is comprised of trusted thought leaders, known for being change agents in the industry and having the respect of their peers throughout their career and community.
“The management team could not be more pleased with the addition of these board members and involvement they have with the direction of our company. We are fortunate and thrilled to have such talented and experienced industry veterans and look forward to their many contributions,” said James Gianoutsos, founder and president of RIMSYS.
As advocates and ambassadors of RIMSYS, the board supports the management team through strategic analysis, consultation, and providing professional expertise and guidance to help navigate and mitigate potential risks, discover opportunities, and define benchmarks for continued success and organizational growth.
“RIMSYS is a very unique product in the marketplace, so it’s only fitting that we bring on such unique minds to the board. Their expertise and vision are exactly what is needed to help us improve our business, our technology and expand our product offerings,” said Brad Ryba, chief technology officer of RIMSYS.
The current advisory board members include:
Speer has over 20 years of experience in the medical device industry that includes quality management, product development, and project management at Creo Quality, Cook Inc., Theron Inc., and Maetrics LLC. He is experienced in managing multiple projects and taking medical device concepts through development, regulatory submission, and ultimately to market. Additionally, Speer is an expert in the design and implementation of U.S. Food and Drug Administration (FDA)-compliant quality management systems and is an active contributor at MedCity News, Med Device Online, Quality Digest, QMed, and is the host of the most downloaded podcast in the industry, The Global Medical Device Podcast. Speer currently serves as the founder and vice president of quality assurance/regulatory affairs at Greenlight Guru, an eQMS (quality management system) that is specifically designed for the medical device industry.
Ferguson has over 15 years of global medical device quality and regulatory affairs experience managing class I, II, and III medical devices and consumer products for numerous global organizations. He has successfully led global quality and regulatory projects and teams through FDA, ISO, consumer safety audits, and quality system remediation activities and has in-depth knowledge of the current regulatory landscape. Ferguson currently serves as director of Quality Assurance for TransEnterix Inc.
McKean has over 25 years of medical device industry experience as a regulatory professional specializing in quality and regulatory (Q&R) compliance, design controls, and Q&R related mergers and acquisitions. During his career, McKean has focused on implementing and maintaining design controls, product submissions, quality management systems internal to his company and for newly acquired companies, corporate Q&R internal audit program, and performing Q&R due diligence audits on target companies. Most recently, McKean has led a corporate-wide MDSAP compliance initiative and is focusing on the EU MDR implementation. He currently serves as director of Q&R Operations at Philips Healthcare.
Price has over 15 years of medical device industry experience as a quality assurance and regulatory affairs professional. He is currently focused on the development of strategies and solutions to establish and maintain compliance in today's fast-paced regulatory environment to enable businesses to meet the demands of the global market. Price is cognizant of dynamic and complex market requirements and the need for effective tools and solutions to allow businesses to maintain continued regulatory compliance. Price currently serves as head of Postmarket Surveillance at Philips Healthcare.
RIMSYS is a regulatory information management (RIM) platform designed specifically for the medical device industry. RIMSYS offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, regulatory documents, changing regulations, and more.