Our unrivaled collective knowledge and risk-balanced approach bring transformative solutions to every project we undertake. Leading industry experts offer wisdom, honesty, and friendly collaboration at every turn, making for a rewarding partnership centered on your success.
RQM+ has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product(s) to market. What's more, we're using the MDR and IVDR to make positive business impacts and set your organization up for greater success.
Quality Management Systems
RQM+ uses a customized and business-balanced approach along with best and proven practices to developing and remediating quality systems. And our dedicated global audit team has you covered, from internal and supplier audits to mock FDA inspections.
Design Quality Engineering
& Manufacturing QA
Our design assurance, risk management, and manufacturing quality experts help you create and manufacture your very best device and stay competitive, while ensuring compliance to the latest regulations.
RQM+ provides the all-encompassing solution including strategic leadership, program management, and a tactical team to address all challenges. These include FDA 483's, warning letters and consent decrees, along with notified body non-conformity reports. No challenge is too big.
Requirements for PMS deliverables have grown dramatically thanks to the MDR and IVDR. RQM+ has extensive thought leadership and expertise creating PMS and PMCF/PMPF plans and PSURS, along with development and execution of user surveys. Successful integration of PMS, CERs/PERs, and Risk Management is a key to success.
Clinical Regulatory Affairs
RQM+ CERs and PERs are like no others. Our team of subject matter experts has the unique combination of clinical and regulatory expertise. Led by Amie Smirthwaite, recent Global Head of Clinical Compliance at BSI, we provide an accurate assessment of sufficient clinical/performance data and effective strategies for filling the gaps to enable CE marking.