RQM+ 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 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.
The company’s President, Maria Fagan, commented: “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. 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.”
More information on the integrated companies will be available in the coming months on the RQM+ website.
