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RQM+ Acquires AcKnowledge Regulatory Strategies

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.

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Upcoming Events

BSG LIVE 22

ICC, Birmingham
20th – 23rd June 2022

EBME Expo 2022

Coventry Building Society Arena, Phoenix Way, Rowleys Green, Coventry CV6 6GE
28th - 29th June

Infection 360: What's trending in infection prevention & control

Edgbaston Stadium, Birmingham
27-28 September 2022

IP2022 IS COMING TO BOURNEMOUTH IN OCTOBER 2022

Bournemouth
17-19 October 2022

UKHCA Conference: Listen Up

Pendulum Hotel and Manchester Conference Centre, Manchester
3rd November 2022

MEDICA 2022

Dusseldorf Germany
14th November - 17th November

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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