RQM+, a provider of regulatory, quality, and clinical consulting services for medical device and in vitro diagnostic (IVD) manufacturers, has acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specialising in regulatory affairs consulting for the medical device and IVD industry.
Acquisition of this team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers, and regulatory and quality experts, and adds additional expertise with FDA submissions. AcKnowledge RS has done significant work with novel and/or high-risk devices, focussing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. The acquisition augments the ability of RQM+ to support medical device and IVD companies throughout their entire product life cycle.
Maria Fagan, the company’s president, said: “RQM+ has always had the vision to become the worldwide leader in providing full-service regulatory and quality solutions to the medical device and diagnostic industries. Our exceptional business-balanced solutions, technical expertise and leadership have been key to accelerating the success of life science companies and ultimately improving the lives of people across the globe. We’re excited to announce the acquisition of AcKnowledge Regulatory Strategies, a high-calibre team of experts that specialise in regulatory affairs consulting exclusively for the medical device industry, and that found success supporting companies of all sizes to navigate the premarket submission process. Their unique depth of U.S. regulatory knowledge and strong connections within the regulatory affairs community, only enhance our ability to provide novel and innovative solutions for even the most complicated regulatory submission situations. RQM+ is honoured to have the Acknowledge Regulatory Strategies team join us as we continue to improve lives … the lives of patients, our team members and our clients.”
AcKnowledge RS founder, Allison Komiyama, added: “We are thrilled to join the RQM+ family. RQM+ is an absolute leader in regulatory and quality service industry, and as an integrated team, we have the capacity to support clients throughout the medical device product lifecycle. I am excited to be able to offer clients — from small start-ups to well-established medical device manufacturers — a full range of international regulatory and quality solutions. The regulatory landscape is constantly evolving, and by combining forces, we can support clients with our collective knowledge, expert strategic and tactical service offerings, and best-in-class customer service. The healthcare sector is growing, and we are pleased to have teamed up with RQM+ to support innovation and help drive efforts to improve the lives of patients.”
