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Our Regulatory &amp; Quality Services<\/strong><\/h2>\n\n  \n    <\/div>\n<\/div>\n\n\n\n<p><strong>Tailored Guidance for Every Stage of Your Product Life Cycle<\/strong>&nbsp;<br>No matter where you are in your MedTech journey, our regulatory &amp; quality services are designed to meet your unique challenges. Explore our customized solutions below.&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>.kt-accordion-id40_045024-f1 .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id40_045024-f1 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:0px;padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id40_045024-f1 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;border-top-right-radius:40px;border-bottom-right-radius:40px;border-bottom-left-radius:40px;background:#fff;font-size:30px;text-transform:none;color:#062464;padding-top:40px;padding-right:32px;padding-bottom:40px;padding-left:32px;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id40_045024-f1 .kt-accordion-panel-inner, .kt-accordion-id40_045024-f1 .kt-accordion-panel-inner h1, .kt-accordion-id40_045024-f1 .kt-accordion-panel-inner h2, .kt-accordion-id40_045024-f1 .kt-accordion-panel-inner h3, .kt-accordion-id40_045024-f1 .kt-accordion-panel-inner h4, .kt-accordion-id40_045024-f1 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#062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_045024-f1:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id40_045024-f1 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id40_045024-f1 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 1024px){.kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 767px){.kt-accordion-id40_045024-f1 .kt-accordion-inner-wrap{display:block;}.kt-accordion-id40_045024-f1 .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id40_045024-f1 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id40_045024-f1 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id40_045024-f1 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id40_045024-f1 kt-accordion-has-5-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane40_c14a0c-80\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Design Quality Engineering &amp; Manufacturing QA<\/strong>&nbsp;<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">RQM+ integrates regulatory insight with design and manufacturing quality assurance to ensure your product meets global standards from the ground up. Our experts support design history file (DHF) development, design control optimization, and integration of quality processes into manufacturing environments to minimize risk and ensure compliance.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\" style=\"margin-top:var(--wp--preset--spacing--32)\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane40_330577-91\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Post-Market Clinical Follow-Up (PMCF)<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">We provide expert strategy and execution for PMCF to meet evolving EU MDR requirements. Our team develops actionable PMCF plans and reports that satisfy notified body expectations, reduce regulatory delays, and help you continuously monitor product performance and safety in the field.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-4 kt-pane40_411cb1-c9\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong>Combination Products Regulatory Support<\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">Our team understands the nuanced requirements for drug-device and biologic-device combinations. We develop regulatory strategies aligned with U.S. FDA and EU expectations, providing expert support across development, submissions, and post-market compliance for combination products.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane40_274644-ef\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">CAPA &amp; Complaints<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">RQM+ streamlines your CAPA and complaints processes, quickly identifying root causes and implementing sustainable resolutions, reducing compliance risks and enhancing patient safety.<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>.kt-accordion-id40_983c2d-08 .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id40_983c2d-08 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:0px;padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id40_983c2d-08 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid 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):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_983c2d-08:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id40_983c2d-08:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id40_983c2d-08:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id40_983c2d-08:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id40_983c2d-08 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id40_983c2d-08 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id40_983c2d-08 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id40_983c2d-08 .kt-accordion-header-wrap 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.kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id40_983c2d-08 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id40_983c2d-08 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id40_983c2d-08 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id40_983c2d-08 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id40_983c2d-08 kt-accordion-has-6-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane40_4c2baa-79\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Quality Management <\/strong><br><strong>Systems<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">We build and enhance QMS programs that are scalable, inspection-ready, and aligned with ISO 13485, FDA QSR, EU MDR and IVDR, MDSAP, and more. Whether you need support for initial implementation, optimization, or full remediation, we deliver right-sized systems tailored to your operations.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\" style=\"margin-top:var(--wp--preset--spacing--32)\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-4 kt-pane40_76f00a-3c\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong>Acquisition Integration &amp; Quality System Harmonization<\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">Mergers and acquisitions (M&amp;A) require seamless quality system integration. RQM+ offers proven strategies to consolidate and harmonize QMSs across legacy organizations, minimizing disruption and accelerating compliance across multisite operations.&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\" style=\"margin-top:var(--wp--preset--spacing--32)\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane40_2b9327-80\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong><strong>Proven Global Regulatory Success<\/strong><\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">Whether you&#8217;re navigating regional regulatory challenges or managing global compliance, RQM+ delivers the strategic insights and execution that drive results. Our team of seasoned professionals \u2014 including former regulators and industry specialists \u2014 brings unmatched experience across therapeutic areas and device types.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\" style=\"margin-top:var(--wp--preset--spacing--32)\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane40_f8efe3-a5\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong><strong>Supplier &amp; Purchasing Controls<\/strong><\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">We help you establish robust supplier and purchasing controls, ensuring quality throughout your supply chain to consistently meet regulatory expectations and maintain operational excellence.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\" style=\"margin-top:var(--wp--preset--spacing--32)\"><\/div>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n\n<div class=\"wp-block-group alignfull is-layout-constrained wp-container-core-group-is-layout-b7e8d9d7 wp-block-group-is-layout-constrained\" style=\"padding-top:0px;padding-right:0px;padding-left:0px\">\n<div class=\"wp-block-group alignwide has-light-gray-background-color has-background is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group has-body-font-size is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px;padding-bottom:0px\">\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><section id=\"decorative-image-block_4e99ec2afbaa734e0ca1ef7bac21fa0f\" class=\"block-decorative-image\">\n    <div class=\"decorative-image-container\">\n        <div class=\"decorative-image-background\" style=\"background-color: #ff4ca5; width: 400px;\">\n            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/woman-on-phone.jpg\" width=\"400\" height=\"400\"  alt=\"\" \/>\n        <\/div>\n    <\/div>\n<\/section>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p style=\"font-size:28px\">RQM+ RA\/QA consulting encompasses a wide spectrum of specialties with hundreds of industry-leading consultants across the globe. Our strategic acumen and first-hand experience spans <a href=\"https:\/\/www.rqmplus.com\/expertise\/medical-devices\/\">medical devices<\/a>, <a href=\"https:\/\/www.rqmplus.com\/expertise\/ivd\/\">IVDs<\/a>, <a href=\"https:\/\/www.rqmplus.com\/expertise\/software-enabled-products\/\">software-enabled products<\/a>, <a href=\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\">combination products<\/a>, and <a href=\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/\">companion diagnostics<\/a>. RQM+ understands the nuances and decisions our clients confront across device types.<\/p>\n\n\n\n<p style=\"font-size:28px\">While MedTech regulations continue to evolve, our team remains at the forefront and primed to help our clients navigate RA\/QA challenges with business-balanced solutions.&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<section id=\"content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0\" class=\"block-content-list alignwide has-image\">\n    \n    <style>\n                #content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0 .clb-image {\n            background: url(https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/person-typing-on-computer.jpg) center center \/ cover no-repeat;\n        }\n            <\/style>\n\n\n    <div class=\"content-list-block-container\">\n        <div class=\"clb-bg clb-bg-1\"><\/div>\n        <div class=\"clb-bg clb-bg-2\"><\/div>\n        <div class=\"clb-inside\">\n            \n            <div class=\"clb-header\">\n                \n\n<h2 class=\"wp-block-heading pink-header has-pink-color has-text-color has-link-color wp-elements-172c6ef94dbd73d95b09eeb1918c97b2\"><strong>Why Choose RQM+ for RA\/QA Services?<\/strong><\/h2>\n\n\n\n<p class=\"white-text\">We apply our comprehensive expertise and innovative tools to accelerate your success:<\/p>\n\n\n            <\/div>\n            <div class=\"clb-list\">\n                <div class=\"wp-block-columns\">\n                    <div class=\"wp-block-column\">\n    \n                        <ul>\n                                                                \n                                        \n                                    <li id=\"content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0-row-0\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/head-gear.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Consult with Experts<\/h3>\n                                            <p class=\"list-text\">Former FDA, notified body, and European regulators become part of your team; largest and most knowledgeable consulting service in the market.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0-row-1\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/globe.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Global Success<\/h3>\n                                            <p class=\"list-text\">Proven track record of submissions across the U.S., Europe, and U.K.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0-row-2\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/RQM-Icon-White-Outline_65.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Tech-Enabled Advantage<\/h3>\n                                            <p class=\"list-text\">Technology-driven insights to streamline compliance and documentation.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0-row-3\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/gear-infinity.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">End-to-End Support<\/h3>\n                                            <p class=\"list-text\">From product concept through post-market management.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9c6c588afc97ecc6a4899e6f39b1a5e0-row-4\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/person-speaking.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Personalized Service<\/h3>\n                                            <p class=\"list-text\">Comprehensive and tailored solutions that address your unique needs and challenges\u200b\u200b.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                        <\/ul>\n    \n                    <\/div>\n                                            <div class=\"wp-block-column\" style=\"flex-basis: 40%;\">\n                            <div class=\"clb-image-contain\">\n                                <div class=\"clb-image clb-img-echo\"><\/div>\n                            <\/div>\n                        <\/div>\n                                        \n                <\/div>\n            <\/div>\n            \n        <\/div>\n        \n    <\/div>\n<\/section>\n\n\n<div id=\"rqm-divider-block_bcb0c1354f695fb1d345ea1ad7a4384a\" class=\"block-rqm-divider rqm-dots-animate alignright\" style=\"\">\n    <div class=\"rqm-divider\">\n  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src=\"https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/rqm-dots-mobile.avif\" alt=\"\" width=\"427\" height=\"40\" \/>\n    <\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-484a42c12eb7cc9da153d8945f5a5896\"><strong>Proven Success Across MedTech<\/strong><\/h2>\n\n\n\n<p>Join other innovators who trust RQM+ to deliver exceptional results.&nbsp;<\/p>\n\n\n<div id=\"slider-block_8c356b4bf2786035e8d5a8a547d65082\" class=\"block-slider\">\n\n    <div class=\"sc-block-carousel\" data-slick='{\"arrows\": true, \"dots\": true, \"autoplay\": true}'>\n        \n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cI wanted to extend my thanks and appreciation for all of the RQM+ team and especially our project lead. I&#8217;ve been doing this for almost 20 years with multiple FDA clearances, so I know how nontrivial it is to be a professional in our field. Our project lead is a true expert with significant knowledge, experience and a very balanced common sense. Moreover, they have a rare talent to differentiate between major and minor, and by this to allow the leading team to focus on the more critical aspects of the submission. At the beginning of the project, I&#8217;ve evaluated several groups and decided to move forward with RQM+, especially due to the impression I got from our project lead and it proved itself. Again, many thanks and for many more successful projects. Cheers!\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">CEO, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cRQM+ provides unrivaled support and has been instrumental in helping our company achieve its regulatory goals. RQM+ is easy to work with, communicates often, and provides high quality deliverables that exceed expectations. I cannot recommend their services enough!\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Regulatory Compliance Manager, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cOur quality and regulatory expert is a reliable resource always willing to help and consistently providing clear, actionable responses.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Senior Regulatory Affairs Specialist, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cIf our regulatory consultant were my only experience with RQM+, I&#8217;d be rating her an 11 instead of a 10! Truly excellent.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Senior Regulatory Affairs Specialist, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cYou have rockstars on your team who are true experts in all things med device regulatory! I have had positive experiences with all RQM+ colleagues and it was reassuring to know the team and their expertise was there for guidance.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Principal Regulatory Specialist, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cI was very pleased with the service provided by the 2 regulatory resources that were part of my project. Their level of expertise on the FDA registrations and understanding of the requirements drive us to a successful clearance of 4 different family of products, in addition both of them were always available for consultation within reasonable amount of time.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Project Engineer, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-5628178f1f3ff7b9ff80bb98d536f913\"><strong>Flexible Partnering Solutions<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing.jpg\" alt=\"Four professionals engaged in a meeting in a modern office. One man is standing and speaking while the others, seated around a table with a laptop and glasses of water, listen attentively.\" class=\"wp-image-1301\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing.jpg 800w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing-768x512.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Outsourcing<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. <a href=\"https:\/\/www.rqmplus.com\/contact\/\">Partner with us<\/a>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1024x683.jpg\" alt=\"Two professional women standing in a bright office space, one holding a folder and the other using a tablet, engaged in discussion.\" class=\"wp-image-976\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1024x683.jpg 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-768x512.jpg 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1536x1024.jpg 1536w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Consulting<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+<br>consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. <a href=\"https:\/\/www.rqmplus.com\/contact\/\">Partner with us<\/a>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1024x683.jpg\" alt=\"\" class=\"wp-image-1223\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1024x683.jpg 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-768x512.jpg 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1536x1024.jpg 1536w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Staff Augmentation<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand<br>professionals, functional service support, fast deployment for tight timelines, and<br>contract-to-hire options that integrate seamlessly with your team. <a href=\"https:\/\/www.rqmplus.com\/match-with-a-contractor\/\">Match with a contractor<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>RQM+ RA\/QA consulting encompasses a wide spectrum of specialties with hundreds of industry-leading consultants across the globe. Our strategic acumen&#8230;<\/p>\n","protected":false},"author":2,"featured_media":976,"parent":37,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"_acf_changed":true,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-40","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"card_info":{"title":"Regulatory &amp; Quality","link":"https:\/\/www.rqmplus.com\/solutions\/regulatory-quality\/","link_target":"_self","name":"Page","slug":"page","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper.jpg","excerpt":"RQM+ RA\/QA consulting encompasses a wide spectrum of specialties with hundreds of industry-leading consultants across the globe. 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