Enhancing our ability to provide novel and innovative solutions for even the most complicated regulatory submission situations.
MONROEVILLE, Pa. — December 20, 2021 — RQM+, the preeminent international provider of regulatory, quality and clinical consulting services for medical device and in vitro diagnostic (IVD) manufacturers, today announced that it has acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. Acquisition of this impressive 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, focusing 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.
“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,” said the company’s President, Maria Fagan. “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-caliber team of experts that specialize 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 honored 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.”
“We are thrilled to join the RQM+ family,” said AcKnowledge RS founder, Allison Komiyama. “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 startups 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 health care 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.”
More information on the integrated companies will be available in the coming months on our website.
RQM+ is the leading international provider of regulatory, quality and clinical consulting services for medical device and diagnostics manufacturers. RQM+ delivers transformative solutions to clients by providing unrivaled collective knowledge and expertise, fueled by passion for client success. RQM+ experts are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, visit RQMplus.com.
About AcKnowledge Regulatory Strategies
AcKnowledge Regulatory Strategies (AcKnowledge RS) specializes in regulatory affairs consulting for the medical device and in vitro diagnostic (IVD) industry. AcKnowledge RS provides strategic advisory guidance and U.S. FDA regulatory submission support for novel and complex devices, including De Novo, Premarket Approval (PMA) and Breakthrough Device Designation applications. In addition to having a team with deep U.S. regulatory and FDA experience, AcKnowledge RS brings to its clients a vast network of current and former FDA reviewers, scientists, engineers and regulatory/quality experts. AcKnowledge RS strives to work with the FDA to ease the review process and get devices on the market faster. For more information, visit AcKnowledge-RS.com.