RQM+ furthers regulatory knowledge with consulting firm purchase


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 (AcKnowledge RS), a firm that focuses on regulatory affairs consulting for the medical device and IVD industry.

The acquisition boosts the 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 work in the field of novel and/or high-risk devices, concentrating on pre-submissions, 510(k)s, investigation device exemptions (IDEs), premarket approvals (PMAs), De Novos, Breakthrough Designation requests and Safer Technology Program requests. The deal strengthens the ability of RQM+ to support medical device and IVD companies during their entire product life cycle.

“ … 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,” says Maria Fagan, RQM+ president. “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. 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.”



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