RQM+, an international provider of regulatory, quality and clinical consulting services for medical device and in vitro diagnostic (IVD) manufacturers, has acquired AcKnowledge Regulatory Strategies, a San Diego-based firm specialising in regulatory affairs consulting for the medical device and IVD industry.
Acquisition of the team enhances the company’s network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions.
AcKnowledge has done significant work with novel and high-risk devices. The acquisition augments the ability of RQM+ to support medical device and IVD companies throughout their entire product life cycle, the company says.
RQM+ President, Maria Fagan said: “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 US 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.”
“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.”
