PITTSBURGH, Dec. 19, 2022 – RQM+ today announced the launch of its clinical trial services division to complete its full complement of MedTech contract research organization (CRO) services. Building upon 40 years of regulatory and quality expertise with the world’s largest global team, RQM+ now offers comprehensive laboratory testing, product development, reimbursement strategy and clinical trial services to support the entire product lifecycle for medical devices, digital therapeutics and diagnostics.
“We have fully evolved our capabilities to become the MedTech partner of choice for clients who want to reduce their commercialization risk by providing all the services needed to launch their products in the market and keep them there,” said CEO Margaret Keegan. “With the strongest regulatory consulting team in the MedTech industry, our trusted experts provide support from the early development stage to commercialization, all within one organization. To deliver the high-quality clinical trials our clients expect, we are delighted to have someone with the depth of expertise that David Novotny brings to lead our trial services business.”
Novotny, chief operating officer for trial services, has more than 20 years of MedTech clinical trial leadership experience in trial operations, consulting and device research across North America, Europe and Asia-Pacific. He previously held strategic leadership positions managing all trial services for several global MedTech CROs.
“I am thrilled to join RQM+ to deliver on the vision of one seamless commercialization platform to help MedTech manufacturers mitigate risk,” said Novotny. “Our strategy includes new digital tools to ensure industry-leading transparency, speed and agility, which will enable clients to make better data-driven decisions for patients.”
He holds a bachelor’s degree in physiology and business administration from the University of Iowa.
RQM+ is a leading MedTech CRO with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive laboratory testing, product development, reimbursement strategy and clinical trial services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for eight of the top 10 medical device manufacturers and seven of the top 10 IVD companies. For more information, visit RQMplus.com.