Quality Management鈥擬eet Your Quality Goals

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class="hidden-on-mobile" />Quality and Compliance</h4></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_1 et_pb_css_mix_blend_mode_passthrough et-last-child et_pb_column_empty"> </div> </div> </div><div class="et_pb_section et_pb_section_1 et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_1"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: center;" class="dark-green">DELIVER MEDICAL DEVICES THAT EXCEED YOUR QUALITY GOALS</h2></div> </div> </div> </div><div class="et_pb_row et_pb_row_2 et_pb_equal_columns"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_3 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_image et_pb_image_0"> <span class="et_pb_image_wrap "><img fetchpriority="high" decoding="async" width="600" height="599" src="https://www.arenasolutions.com/wp-content/uploads/Closed-Loop-Quality-Management.jpg" alt="Closed-Loop Quality Management graphic" title="Closed-Loop-Quality-Management" srcset="https://www.arenasolutions.com/wp-content/uploads/Closed-Loop-Quality-Management.jpg 600w, https://www.arenasolutions.com/wp-content/uploads/Closed-Loop-Quality-Management-300x300.jpg 300w, https://www.arenasolutions.com/wp-content/uploads/Closed-Loop-Quality-Management-500x500.jpg 500w, https://www.arenasolutions.com/wp-content/uploads/Closed-Loop-Quality-Management-400x400.jpg 400w" sizes="(max-width: 600px) 100vw, 600px" class="wp-image-26296" /></span> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>The burden to get compliant medical devices to market is great. And as <a href="/solutions/compliance-management/medical-devices/">regulatory standards</a>, market requirements, and device complexities have evolved鈥攕o, too, has the weight of the burdens these leaders face.</p> <p>We help you overcome these challenges to eliminate product launch process delays, reduce compliance risks, and remove barriers that impede innovation.</p> <p><a href="/platform/qms/">Arena Quality Management System (QMS)</a><strong></strong>聽software connects closed-loop <a href="/solutions/quality-management/">quality management</a> with <a href="/solutions/product-development/">product development</a> processes in a single system. This product-centric approach simplifies compliance and reduces internal or external FDA, EU MDR, or ISO audit risks.</p></div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_2 et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_3"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_5 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: center;" class="dark-green">Arena QMS Ensures Compliance Through Product Launch</h2></div> </div> </div> </div><div class="et_pb_row et_pb_row_4"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_6 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_4 et_pb_text_align_center et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>Our closed-loop quality management system provides quality teams with better transparency and traceability throughout the entire new product development and introduction process. This includes supporting compliant聽<a href="/solutions/design-controls/">design controls</a>. With Arena QMS, you can focus on what you do best. <a href="https://www.arenasolutions.com/solutions/software-validation/">Arena Validate</a> makes it easy to comply with software validation regulations under ISO 13485 and FDA Title 21 CFR 820.30.</p></div> </div> </div> </div><div class="et_pb_row et_pb_row_5 left-right-blurbs-row et_pb_equal_columns et_pb_gutters4"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_7 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_image et_pb_image_1"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="800" height="450" src="https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Truth.jpg" alt="Quality Product Production" title="QMD-Quality-Truth" srcset="https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Truth.jpg 800w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Truth-300x169.jpg 300w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Truth-500x281.jpg 500w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Truth-768x432.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" class="wp-image-26302" /></span> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_8 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_5 et_pb_text_align_left et_pb_text_align_right-tablet et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Trust a Single Source of Truth</h4> <p><span>Arena QMS enables your teams to manage quality (DMRs, DHFs, SOPs, CAPAs) and training records in context to the entire <a href="/solutions/item-bom-management/">product record</a>聽(items, BOMs, AML/AVL). We streamline closed-loop quality management processes to reduce compliance and audit risks while enabling continuous improvement.聽</span></p></div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_3 et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_6 left-right-blurbs-row image-right et_pb_equal_columns et_pb_gutters4"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_9 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_6 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Demonstrate Training Competency聽</h4> <p><span>Track employee and partner training on new and revised standards, instructions, and procedures. <a href="/solutions/training-management/">Arena Training</a> manages your employee and partner training plans and ensures everyone can demonstrate competency.聽</span></p></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_10 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_image et_pb_image_2"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="800" height="450" src="https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Training-Competency.jpg" alt="Employee Training Quality" title="QMD-Quality-Training-Competency" srcset="https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Training-Competency.jpg 800w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Training-Competency-300x169.jpg 300w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Training-Competency-500x281.jpg 500w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Training-Competency-768x432.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" class="wp-image-26300" /></span> </div> </div> </div> </div><div class="et_pb_section et_pb_section_4 et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_7 left-right-blurbs-row et_pb_equal_columns et_pb_gutters4"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_11 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_image et_pb_image_3"> <span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="800" height="450" src="https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Product-Quality-Tests.jpg" alt="Quality Tests Checkmark" title="QMD-Quality-Product-Quality-Tests" srcset="https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Product-Quality-Tests.jpg 800w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Product-Quality-Tests-300x169.jpg 300w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Product-Quality-Tests-500x281.jpg 500w, https://www.arenasolutions.com/wp-content/uploads/QMD-Quality-Product-Quality-Tests-768x432.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" class="wp-image-26298" /></span> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_12 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_7 et_pb_text_align_left et_pb_text_align_right-tablet et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4><span>Develop Accurate Product Quality Tests</span></h4> <p><span>Synchronize inspection tests with the product revision. Arena integrates with quality control, CRM, and manufacturing execution systems. Quality assurance teams can define, revise, and review test specifications fast.</span></p></div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_5 et_pb_with_background et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_8"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_13 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_8 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: center;"><span style="color: #ffffff;">Design Safe, Innovative, and Compliant Products</span></h2></div> </div> </div> </div><div class="et_pb_row et_pb_row_9"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_14 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_9 et_pb_text_align_center et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><span>Medical device manufacturers face many challenges鈥攊ncluding 510(k) submissions and premarket approvals (PMA)鈥攊n their product launch journey before they can sell devices commercially. Arena QMS accelerates the development and delivery of safe products.</span></p> <p>Arena QMS helps your quality teams:</p></div> </div> </div> </div><div class="et_pb_row et_pb_row_10 five-column-boxes et_pb_equal_columns et_pb_gutters1"> <div class="et_pb_column et_pb_column_1_5 et_pb_column_15 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_blurb et_pb_blurb_0 et_pb_text_align_center et_pb_blurb_position_top et_pb_bg_layout_light"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" src="https://www.arenasolutions.com/wp-content/uploads/Icon-Unify.svg" alt="Icon-Unify" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-64392" /></span></div> <div class="et_pb_blurb_container"> <h4 class="et_pb_module_header"><span>UNIFY</span></h4> <div class="et_pb_blurb_description"><p><span>quality and product processes for better control and traceability</span></p></div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_5 et_pb_column_16 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_blurb et_pb_blurb_1 et_pb_text_align_center et_pb_blurb_position_top et_pb_bg_layout_light"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" src="https://www.arenasolutions.com/wp-content/uploads/Icon-Item-Lookup.svg" alt="Icon-Item Lookup" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-64396" /></span></div> <div class="et_pb_blurb_container"> <h4 class="et_pb_module_header"><span>Identify</span></h4> <div class="et_pb_blurb_description"><p><span>and resolve issues with closed-loop corrective and preventive actions (CAPA)</span></p></div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_5 et_pb_column_17 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_blurb et_pb_blurb_2 et_pb_text_align_center et_pb_blurb_position_top et_pb_bg_layout_light"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" src="https://www.arenasolutions.com/wp-content/uploads/Icon-Software-Validation.svg" alt="Icon-Software Validation" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-64155" /></span></div> <div class="et_pb_blurb_container"> <h4 class="et_pb_module_header"><span>Ensure</span></h4> <div class="et_pb_blurb_description"><p><span>compliance with FDA 21 CFR Part 820, Part 11, ISO 13485, EU 2017/745, and EU 2017/746 </span></p></div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_5 et_pb_column_18 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_blurb et_pb_blurb_3 et_pb_text_align_center et_pb_blurb_position_top et_pb_bg_layout_light"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" src="https://www.arenasolutions.com/wp-content/uploads/Icon-Requirements-Management.svg" alt="Icon-Requirements Management" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-64181" /></span></div> <div class="et_pb_blurb_container"> <h4 class="et_pb_module_header"><span>Adhere</span></h4> <div class="et_pb_blurb_description"><p>to current good manufacturing practices (cGMPs)</p></div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_5 et_pb_column_19 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_blurb et_pb_blurb_4 et_pb_text_align_center et_pb_blurb_position_top et_pb_bg_layout_light"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" src="https://www.arenasolutions.com/wp-content/uploads/Icon-Environment-Export.svg" alt="Icon-Environmental Export" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-64217" /></span></div> <div class="et_pb_blurb_container"> <h4 class="et_pb_module_header"><span>COMPLY</span></h4> <div class="et_pb_blurb_description"><p><span>with software validation regulations to reduce risks</span></p></div> </div> </div> </div> </div> </div><div class="et_pb_row et_pb_row_11"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_20 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_10 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>CHECK OUT THE LIFE SCIENCES INDUSTRIES WE SERVE</h4></div> </div><div class="et_pb_button_module_wrapper et_pb_button_0_wrapper et_pb_button_alignment_center et_pb_module "> <a class="et_pb_button et_pb_button_0 white-button et_pb_bg_layout_light" href="/industries/">INDUSTRIES</a> </div> </div> </div> </div><div class="et_pb_section et_pb_section_6 cta-section et_clickable et_pb_with_background et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_12 et_pb_equal_columns et_pb_gutters1"> <div class="et_pb_with_border et_pb_column_1_2 et_pb_column et_pb_column_21 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_11 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2 style="text-align: right;"><span style="color: #000000;">COMPARE</span><br /><span style="color: #000000;">QMS SOLUTIONS</span></h2></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_22 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_12 et_pb_text_align_left et_pb_text_align_center-tablet et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p style="margin-bottom: 0 !important;"><span>See why Arena’s product-centric QMS is better.</span></p></div> </div><div class="et_pb_button_module_wrapper et_pb_button_1_wrapper et_pb_button_alignment_left et_pb_button_alignment_tablet_center et_pb_module "> <a class="et_pb_button et_pb_button_1 white-button purple-outline et_pb_bg_layout_light" href="/platform/qms/comparison/">compare now</a> </div> </div> </div> </div><div id="customer-logo-slider" class="et_pb_section et_pb_section_7 et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_13"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_23 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_13 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h2>LEADING INNOVATORS TRUST ARENA</h2></div> </div><div class="et_pb_module mt-divi-logo-slider mt-divi-logo-slider_0"> <div class="et_pb_module_inner"> <div 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$('#mt-slider-1026928017').slick({ dots: false, arrows: true, prevArrow: '<img decoding="async" class="slider-left-arrow" src="https://www.arenasolutions.com/wp-content/plugins/mt-divi-logo-slider/includes/left-arrow.svg" alt="previous slide navigation arrow" />', nextArrow: '<img decoding="async" class="slider-right-arrow" src="https://www.arenasolutions.com/wp-content/plugins/mt-divi-logo-slider/includes/right-arrow.svg" alt="next slide navigation arrow" />', autoplay: true, autoplaySpeed: 5000, speed: 1000, infinite: true, slidesToScroll: 5, slidesToShow: 5, swipe: true, draggable: true, touchMove: true, pauseOnHover: false, responsive: [ { breakpoint: 1025, settings: { slidesToShow: 5, slidesToScroll: 5, } }, { breakpoint: 769, settings: { slidesToShow: 3, slidesToScroll: 3 } }, { breakpoint: 481, settings: { slidesToShow: 2, slidesToScroll: 2 } } ] }); }); }); </script> </div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_8 et_pb_with_background et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_14 et_pb_equal_columns et_pb_gutters1"> <div class="et_pb_with_border et_pb_column_1_3 et_pb_column et_pb_column_24 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_14 et_pb_text_align_center et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a class="video-popup-button" href="/wp-content/uploads/Somalogic_Customer_Testimonial.mp4"><img loading="lazy" decoding="async" class="wp-image-18865 size-medium alignright" src="https://www.arenasolutions.com/wp-content/uploads/Somalogic-Testimonial-LucasFernandez-300x169.jpg" alt="" width="300" height="169" srcset="https://www.arenasolutions.com/wp-content/uploads/Somalogic-Testimonial-LucasFernandez-300x169.jpg 300w, https://www.arenasolutions.com/wp-content/uploads/Somalogic-Testimonial-LucasFernandez-500x282.jpg 500w, https://www.arenasolutions.com/wp-content/uploads/Somalogic-Testimonial-LucasFernandez-768x433.jpg 768w, https://www.arenasolutions.com/wp-content/uploads/Somalogic-Testimonial-LucasFernandez-248x140.jpg 248w, https://www.arenasolutions.com/wp-content/uploads/Somalogic-Testimonial-LucasFernandez.jpg 852w" sizes="(max-width: 300px) 100vw, 300px" /></a></p></div> </div> </div><div class="et_pb_column et_pb_column_2_3 et_pb_column_25 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_15 et_pb_text_align_left et_pb_text_align_center-tablet et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>SOMALOGIC RELIES ON ARENA</h4> <p>Arena’s SaaS solutions help Somalogic manage their digital product and quality records across dispersed teams.</p></div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_9 cta-section et_pb_with_background et_section_regular et_section_transparent" > <div class="et_pb_row et_pb_row_15 et_pb_equal_columns et_pb_gutters1"> <div class="et_pb_with_border et_pb_column_2_3 et_pb_column et_pb_column_26 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_16 et_pb_text_align_left et_pb_text_align_center-tablet et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h3 style="text-align: right;">QUALITY TALK</h3> <p style="text-align: right;">Sanjay Banerjee, COO at Accuryn Medical, shares insights about quality and compliance strategies.</p></div> </div> </div><div class="et_pb_column et_pb_column_1_3 et_pb_column_27 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_text et_pb_text_17 et_pb_text_align_center et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a class="video-popup-button" href="/wp-content/uploads/Customer-Success-Sanjay-Banerjee-v01.mp4"><img loading="lazy" decoding="async" class="wp-image-16768 size-medium alignleft" src="https://www.arenasolutions.com/wp-content/uploads/Sanjay-Video-Thumbnail-300x169.jpg" alt="Sanjay Banerjee, COO Potrero - Watch Video" width="300" height="169" /></a></p></div> 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