RQM+ | Global MedTech Service Provider Accelerating Compliance and Market Success

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role="menuitem" target="_self">Complete Managed Outsourcing</a></li> </ul> </div></span> </div> </div> <div class="level-2__column feat light "> <div class="level-2__menu-featured"> <h3 style="text-align: center;">PFAS White Paper</h3> <div style="text-align: center; margin-bottom: 15px;"><a href="https://resources.rqmplus.com/rqmplus-white-paper-are-we-equipped-to-handle-a-pfas-free-future" rel="noopener" target="_blank" linktext=""><img src="https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=194&height=194&name=Design%201.png" width="194" height="194" loading="lazy" alt="Design 1" style="width: 194px; height: auto; max-width: 100%;" srcset="https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=97&height=97&name=Design%201.png 97w, https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=194&height=194&name=Design%201.png 194w, https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=291&height=291&name=Design%201.png 291w, https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=388&height=388&name=Design%201.png 388w, https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=485&height=485&name=Design%201.png 485w, https://www.rqmplus.com/hs-fs/hubfs/Design%201.png?width=582&height=582&name=Design%201.png 582w" sizes="(max-width: 194px) 100vw, 194px"></a></div> <div style="text-align: center; margin-bottom: 15px; font-size: 14px; line-height: 1.25;"><span>Are We Equipped to Handle a PFAS-Free Future?</span></div> <div style="text-align: center;"><a href="https://resources.rqmplus.com/rqmplus-white-paper-are-we-equipped-to-handle-a-pfas-free-future" class="button" rel="noopener" target="_blank">⬇️ Download Now</a></div> </div> </div> </div> <a href="https://podcasters.spotify.com/pod/show/deviceadvice" class="level-2__call-out level-2__call-out-event"> <div class="level-2__call-out-text"> <h3>Subscribe to the RQM+ Device Advice Podcast</h3> <span class="button">Download Now</span> </div> </a> </div> </li> 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Our team has deep expertise in trial design and implementation for a wide range of products, including medical devices, in vitro diagnostics, combination device-drug products, and Software as a Medical Device (SaMD). Our capabilities span the spectrum of trial phases, including early feasibility studies, first-in-human, pilot, pivotal (510(k), PMA, and CE Mark), post-market and real-world evidence, and PMCF.<br></span></p> <p><a href="/services/clinical-trials" class="learn-more" rel="noopener">Learn more</a></p> </div> </div> </div> <div class="flip-card full dark wow animate__fadeIn " data-wow-delay="0.4s"> <div class="front first"> <div class="image lazy" style="background-image: url(https://www.rqmplus.com/hubfs/GettyImages-640126775-min.jpg); background-position: left bottom; background-size: cover;"> </div> <div class="copy"> <hr> <h2>Maximize your returns with reimbursement</h2> <p>RQM+ helps clients maximize the value, recognition, and return on investment for their product technology. Our experts partner with client teams to develop integrated strategies addressing market analytics, market access, payer engagement, health economic data generation, and evidence development required to demonstrate product value and achieve optimal reimbursement positioning.</p> <p><a href="/services/reimbursement" class="learn-more" rel="noopener">Learn more</a></p> </div> </div> </div> <div class="flip-card half white wow animate__fadeInLeft " data-wow-delay="0.5s"> <div class="front second"> <div class="image lazy" style="background-image: url(https://www.rqmplus.com/hubfs/HD%20Fern%20AI%202023/images/resource-center-placeholders/2.png); background-position: center; background-size: cover;"> </div> <div class="copy"> <hr> <h2>RQM+ launches Smart Authoring within Fern.ai</h2> <p>Fern.ai's Smart Authoring module revolutionizes MedTech regulatory documentation by automating and streamlining document creation and management. This enhances compliance and accuracy, reducing time-to-market for new products. With a single source of truth, dynamic linking, and robust template management, it ensures consistency and team collaboration. RQM+ uses AI and automation to help manufacturers bring life-saving devices to market faster and with greater confidence.</p> <p><a href="https://fern.ai" class="learn-more" rel="noopener" target="_blank">Visit Fern.ai</a></p> </div> </div> </div> <div class="flip-card half dark wow animate__fadeInRight " data-wow-delay="0.6s"> <div class="front first"> <div class="image lazy" style="background-image: url(https://www.rqmplus.com/hubfs/GettyImages-748343193-min.jpg); background-position: left bottom; background-size: cover;"> </div> <div class="copy"> <hr> <h2>Be your best at RQM+</h2> <p>We know the success of RQM+ and our employees go hand in hand. Our tagline is <strong>the plus is the people</strong>, after all. We give talented professionals a supportive and flexible environment to strategically grow their careers, all while advancing global healthcare through MedTech innovation.</p> <p><a href="/careers" class="learn-more" rel="noopener">Read about our core values and open positions</a></p> </div> </div> </div> </div> </div> </section></div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-3 main_body-row-1-padding dnd-section main_body-row-1-background-layers main_body-row-1-background-color"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-4 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_widget_1673454477927" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><section class="section-white" style="padding-bottom: 12px;"> <div class="page-center"> <div class="filtering-tool wow animate__fadeInUp narrow right"> <div class="image"> <img src="https://www.rqmplus.com/hubfs/RQM%20Live/Show%2079/rqm%20homepage%20image.jpg" alt="rqm homepage image"> </div> <div class="copy"> <h3>Ready for the upcoming PFAS restrictions? <strong>We can help.</strong></h3> <p><img src="https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=318&height=77&name=JordiLabs_logo-min.png" width="318" height="77" loading="lazy" alt="JordiLabs_logo-min" style="height: auto; max-width: 100%; width: 318px;" srcset="https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=159&height=39&name=JordiLabs_logo-min.png 159w, https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=318&height=77&name=JordiLabs_logo-min.png 318w, https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=477&height=116&name=JordiLabs_logo-min.png 477w, https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=636&height=154&name=JordiLabs_logo-min.png 636w, https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=795&height=193&name=JordiLabs_logo-min.png 795w, https://www.rqmplus.com/hs-fs/hubfs/JordiLabs_logo-min.png?width=954&height=231&name=JordiLabs_logo-min.png 954w" sizes="(max-width: 318px) 100vw, 318px"></p> <p>Jordi Labs, an RQM+ Company, has built its E&L business on a foundation of 40+ years as polymer experts and has 10+ years’ experience working specifically with PFAS materials.</p> <ul> <li>Supported a customer study for three years to develop a novel fluorinated polymeric system</li> <li>Specialize in tackling the most difficult method development studies for complex sample matrices and analytes</li> <li>Can achieve low level quantitation in the ppb to ppt range</li> <li>Design and perform complex device extraction studies for unique applications</li> <li>Utilize triple quad LC-MS & GC-MS along with Combustion Ion Chromatography to determine total Fluorine content</li> <li>Over 80 analytical techniques available and utilized to provide chemical data and structure</li> </ul> In addition to lab testing, RQM+’s RA/QA Consulting Services team can help you evaluate suppliers, implement device changes and testing, and complete regulatory submissions associated with the upcoming PFAS phase-out.<br><br> <ul> <li>Supplier support: RQM+’s quality assurance engineers review material lists, setup suppliers, and support the design change process. Our regulatory affairs consultants provide change assessments to determine the scope and regulatory impact of any changes.</li> <li>Testing and validation support: RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed and our project management team oversees the project for you.</li> <li>Regulatory submissions: RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies.</li> </ul> <p><a href="https://resources.rqmplus.com/rsvp-live-75-pfas" class="button" rel="noopener">Watch PFAS Presentation and Panel</a><a href="/blog/preparing-for-the-phase-out-of-pfas-in-medtech-manufacturing" class="button" rel="noopener">Read our Technical Brief</a></p> </div> </div> </div> </section></div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-5 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-cell dnd-column" style="" data-widget-type="cell" data-x="0" data-w="12"> <div class="row-fluid-wrapper row-depth-1 row-number-6 dnd-row"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_main_body-module-2" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><section class="section how-we-help-section"> <div class="section-header text-center wow animate__fadeInUp"> <h3>What RQM+ Can Do for You</h3> <h2>Whether you need occasional support with product strategies or a dedicated team that handles all of your commercialization needs, our team is here for you.</h2> </div> <div class="copy"> <svg class="green-triangle" width="1105px" height="942px" viewbox="0 0 1105 942" version="1.1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"> <title>Path</title> <g stroke="none" stroke-width="1" fill="none" fill-rule="evenodd"> <g transform="translate(0.000000, -4570.000000)" fill="#ff4ca5" fill-rule="nonzero"> <polygon transform="translate(552.247407, 5041.000000) scale(-1, 1) translate(-552.247407, -5041.000000) " points="1104.73657 4570 -0.24175109 5512 1104.73657 5512"></polygon> </g> </g> </svg> <p>Our experts are collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations. With former FDA and EU regulators on staff, our team is ready to work with yours to evaluate risk, prioritize the most impactful products, and implement a plan that makes sense for your business.</p> </div> <span class="background-image" style="background-image: url(https://www.rqmplus.com/hubfs/~2021RQM/how-we-help.png);"> <img src="" alt="" class="floating"> </span> </section></div> </div> </div> </div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-7 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_main_body-module-3" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="stats-wrapper section section-dark"> <div class="page-center"> <div class="section-header text-center wow animate__fadeInUp"> <hr> <h2>RQM+ delivers transformative solutions and the results speak for themselves.</h2> </div> <div class="stat-flex"> <div class="counters wow animate__fadeIn" data-wow-delay="0.1s"> <span class="wrap"><span class="symbol prefix top"></span><span class="counter">1,000</span><span class="symbol suffix normal">+</span></span> <span class="stat">Clients</span> </div> <div class="counters wow animate__fadeIn" data-wow-delay="0.2s"> <span class="wrap"><span class="symbol prefix normal"></span><span class="counter">5,000</span><span class="symbol suffix normal">+</span></span> <span class="stat">Completed Projects</span> </div> <div class="counters wow animate__fadeIn" data-wow-delay="0.3s"> <span class="wrap"><span class="symbol prefix top"></span><span class="counter">9.6</span><span class="symbol suffix bottom"></span></span> <span class="stat">Average Net Promoter Score</span> </div> <div class="counters wow animate__fadeIn" data-wow-delay="0.4s"> <span class="wrap"><span class="symbol prefix top"></span><span class="counter">90</span><span class="symbol suffix top">%</span></span> <span class="stat">Repeat Business Rate</span> </div> </div> <div class="columned wow animate__fadeIn"> <div class="columned-copy"> <p style="text-align: center;"><img src="https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=418&name=learning-development.jpg" alt="learning-development" width="418" loading="lazy" style="width: 418px;" srcset="https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=209&name=learning-development.jpg 209w, https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=418&name=learning-development.jpg 418w, https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=627&name=learning-development.jpg 627w, https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=836&name=learning-development.jpg 836w, https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=1045&name=learning-development.jpg 1045w, https://www.rqmplus.com/hs-fs/hubfs/~2021RQM/learning-development.jpg?width=1254&name=learning-development.jpg 1254w" sizes="(max-width: 418px) 100vw, 418px"></p> </div> <div class="columned-copy"> <p style="font-size: 24px;">RQM+ provides comprehensive, high-quality commercialization solutions to help MedTech manufacturers get their products on the market and keep them there. Our experts are our greatest asset and we heavily invest in ongoing learning and development.</p> </div> </div> <div class="banner-slider wow animate__fadeIn"> <div class="banner-slider__nav"> <div class="banner-slider__nav-item" value="banner-slide-1"> <img src="https://www.rqmplus.com/hubfs/Website%20Refresh%20-%20Images%20Jan%202023/Icons/Blue%20and%20pink%20icons/RQM%20Icon%20blue%2067@2x.svg" alt="RQM Icon blue 67@2x"> Regulatory Insights </div> <div class="banner-slider__nav-item" value="banner-slide-2"> <img src="https://www.rqmplus.com/hubfs/Website%20Refresh%20-%20Images%20Jan%202023/Icons/Blue%20and%20pink%20icons/RQM%20Icon%20blue%2057@2x.svg" alt="In The Trenches"> In The Trenches </div> <div class="banner-slider__nav-item" value="banner-slide-3"> <img src="https://www.rqmplus.com/hubfs/Website%20Refresh%20-%20Images%20Jan%202023/Icons/Blue%20and%20pink%20icons/RQM%20Icon%2052%20_white.svg" alt="Industry Leaders"> Industry Leaders </div> <div class="banner-slider__nav-item" value="banner-slide-4"> <img src="https://www.rqmplus.com/hubfs/Website%20Refresh%20-%20Images%20Jan%202023/Icons/Blue%20and%20pink%20icons/RQM%20Icon%20blue%2020@2x.svg" alt="Committee Participation"> Committee Participation </div> </div> <div class="banner-slider__main"> <div class="banner-slide__main-item" id="banner-slide-1"> <div class="inner"> <div class="image" style="background-image: url(https://www.rqmplus.com/hubfs/~2021RQM/solutions-5-regulatory-response.jpg);"> </div> <div class="copy"> <p>Former FDA, competent authority, and notified body leadership</p> </div> </div> </div> <div class="banner-slide__main-item" id="banner-slide-2"> <div class="inner"> <div class="image" style="background-image: url(https://www.rqmplus.com/hubfs/~2021RQM/in-the-trenches.jpg);"> </div> <div class="copy"> <p>Cutting-edge projects, new regulations, and interaction with regulators</p> </div> </div> </div> <div class="banner-slide__main-item" id="banner-slide-3"> <div class="inner"> <div class="image" style="background-image: url(https://www.rqmplus.com/hubfs/~2021RQM/key-service-non-conformance-reports-1.jpg);"> </div> <div class="copy"> <p>Passionate experts, strong professional network, and trusted expertise</p> </div> </div> </div> <div class="banner-slide__main-item" id="banner-slide-4"> <div class="inner"> <div class="image" style="background-image: url(https://www.rqmplus.com/hubfs/~2021RQM/committee-participation.jpg);"> </div> <div class="copy"> <p>Contributions to the content of standards and guidance documents</p> </div> </div> </div> </div> </div> </div> <div class="testimonial-bar"> <div class="copy section wow animate__fadeInLeft"> <div class="page-center"> <p style="text-align: left;"><em>“I am amazed at how much work and the number of decisions that have been made to date on this project! I really appreciate the effort and patience of your entire team!</em></p> <p style="text-align: left;"><strong>Director, Regulatory Affairs </strong><br>IVDR Implementation Project<br>Global Medical Device and Diagnostics Manufacturer<span></span></p> </div> </div> </div> </div></div> </div> </div> </div> <div class="row-fluid-wrapper row-depth-1 row-number-8 dnd-section"> <div class="row-fluid "> <div class="span12 widget-span widget-type-custom_widget dnd-module" style="" data-widget-type="custom_widget" data-x="0" data-w="12"> <div id="hs_cos_wrapper_main_body-module-4" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="saas-featured-resource-7 custom-featured-resource section section-dark"> <div class="page-center"> <div class="row-fluid-wrapper"> <div class="row-fluid three-columns"> <a href="https://www.rqmplus.com/about" class="featured-resource-item"> <div 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