{"id":8368,"date":"2017-03-20T13:32:11","date_gmt":"2017-03-20T13:32:11","guid":{"rendered":"https:\/\/coforge.site\/cigniti_new\/?page_id=8368"},"modified":"2024-07-30T12:38:59","modified_gmt":"2024-07-30T12:38:59","slug":"medical-devices-testing","status":"publish","type":"page","link":"https:\/\/coforge.site\/cigniti_new\/services\/medical-devices-testing\/","title":{"rendered":"Medical Devices Testing"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;main-banner&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Medical Device Testing Services&#8221; font_container=&#8221;tag:h1|font_size:41px|text_align:left|line_height:50px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:600%20bold%20regular%3A600%3Anormal&#8221; css=&#8221;.vc_custom_1585659283311{margin-bottom: 15px !important;}&#8221;][vc_column_text]<\/p>\n<h2 style=\"font-size: 18px; font-weight: 300; line-height: 26px; letter-spacing: -.5px;\">Verification &amp; Validation of Medical Devices used by Dentists, Surgeons, Ophthalmologists, Endocrinologists, &amp; Cardiologists such as surgical instruments, contact lenses &amp; ultrasound scanners, orthopedic implants &amp; hemodialysis machines, cardiac pacemakers, imaging, etc.<\/h2>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;section-bg&#8221;][vc_column][vc_custom_heading text=&#8221;Optimize medical device testing outcomes with our Digital Assurance Services solutions.&#8221; font_container=&#8221;tag:h2|font_size:26px|text_align:left|color:%23000066&#8243; use_theme_fonts=&#8221;yes&#8221;][vc_row_inner][vc_column_inner el_class=&#8221;case-study-box&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1690441287208{padding: 18px !important;background-color: #dd9933 !important;}&#8221;][vc_custom_heading text=&#8221;IoT Assurance improves automation coverage by <strong>50%<\/strong>&#8221; font_container=&#8221;tag:h3|text_align:left|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text css=&#8221;.vc_custom_1709803257653{margin-top: 10px !important;}&#8221;]<a style=\"color: #ffffff;\" href=\"\/resource\/case-studies\/medical-devices-quality-engineering-services\/\">Read Case Study<\/a>[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;case-study-box&#8221; width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1690441296167{padding: 18px !important;background-color: #1e73be !important;}&#8221;][vc_custom_heading text=&#8221;Increase release capacity by <strong>30%,<\/strong> reduce deployment costs by <strong>85%<\/strong>&#8221; font_container=&#8221;tag:h3|text_align:left|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text css=&#8221;.vc_custom_1709803375679{margin-top: 10px !important;}&#8221;]<a style=\"color: #ffffff;\" href=\"\/resource\/case-studies\/healthcare-testing-increased-release-capacity-medical-devices\/\">Read Case Study<\/a>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row bg_type=&#8221;bg_color&#8221; bg_override=&#8221;full&#8221; bg_color_value=&#8221;#000066&#8243; el_class=&#8221;section-bg&#8221;][vc_column][vc_custom_heading text=&#8221;Client Speak&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:center|color:%23ffffff|line_height:40px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][vc_row_inner][vc_column_inner]<div class=\"porto-testimonial wpb_content_element \"><div class=\"testimonial testimonial-style-2 testimonial-with-quotes testimonial-light\"><blockquote class=\"testimonial-carousel white\" style=\"color:#ffffff\"><p>&#8220;Cigniti is a high-quality organization helping contribute to their client&#8217;s success. Cigniti has integrated well with our needs by providing on and offshore capabilities while helping us drive test automation as a key strategy. They partner with us to ensure we are satisfied and on the rare occasion when we are not, they work quickly to address the concern.&#8221;<\/p><\/blockquote><div class=\"testimonial-author\"><p><strong style=\"color:#ffffff\">Director<\/strong><span style=\"color:#ffffff\">IT Quality Assurance in the Services Industry<\/span><\/p><\/div><\/div><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=&#8221;clients section-bg&#8221;][vc_column][vc_custom_heading text=&#8221;Our Key Clients&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:center|color:%23000066|line_height:40px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][vc_row_inner][vc_column_inner][vc_column_text]<\/p>\n<p style=\"text-align: center;\">Here are few of the leading organizations who rely on Cigniti\u2019s Medical Device Testing experts:<\/p>\n<p>[\/vc_column_text]<div class=\"porto-carousel owl-carousel has-ccols ccols-xl-6 ccols-lg-4 ccols-md-3 ccols-sm-2 ccols-1 stage-margin rounded-nav show-nav-hover\" data-plugin-options=\"{&quot;stagePadding&quot;:40,&quot;margin&quot;:10,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplayTimeout&quot;:5000,&quot;autoplayHoverPause&quot;:false,&quot;items&quot;:6,&quot;lg&quot;:4,&quot;md&quot;:3,&quot;sm&quot;:2,&quot;xs&quot;:1,&quot;nav&quot;:&quot;yes&quot;,&quot;dots&quot;:false,&quot;animateIn&quot;:&quot;&quot;,&quot;animateOut&quot;:&quot;&quot;,&quot;loop&quot;:&quot;yes&quot;,&quot;center&quot;:false,&quot;video&quot;:false,&quot;lazyLoad&quot;:false,&quot;fullscreen&quot;:false}\">[vc_single_image image=&#8221;74514&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74513&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74511&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;80753&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74213&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74515&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74517&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74218&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74235&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74214&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;][vc_single_image image=&#8221;74215&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221;]<\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row bg_type=&#8221;bg_color&#8221; bg_override=&#8221;full&#8221; bg_color_value=&#8221;#f2f2f2&#8243; el_class=&#8221;section-bg&#8221;][vc_column][vc_custom_heading text=&#8221;Awards and Recognitions&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:center|color:%23000066|line_height:40px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221; css=&#8221;.vc_custom_1709813229807{margin-bottom: 25px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div class=\"aio-icon-component  vc_custom_1716974309774   style_1\"><div id=\"Info-box-wrap-9022\" class=\"aio-icon-box left-icon\" style=\"\"  ><div class=\"aio-icon-left\"><div class=\"ult-just-icon-wrapper  \"><div class=\"align-icon\" style=\"text-align:center;\">\n<div class=\"aio-icon-img \" style=\"font-size:150px;display:inline-block;\" >\n\t<img decoding=\"async\" class=\"img-icon\" alt=\"MedTech Breakthrough Award\" src=\"https:\/\/coforge.site\/cigniti_new\/wp-content\/uploads\/medtech-breakthrough-award.png\"\/>\n<\/div><\/div><\/div><\/div><div class=\"aio-ibd-block\"><div class=\"aio-icon-description ult-responsive\"  data-ultimate-target='#Info-box-wrap-9022 .aio-icon-description'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  style=\"\"><\/p>\n<p style=\"text-align: left; font-size: 16px !important; margin-bottom: 0px;\">Cigniti Wins \u201cBest IoT Healthcare Platform\u201d in the 2023 MedTech Breakthrough Awards Program<\/p>\n<p><\/div> <!-- description --><\/div> <!-- aio-ibd-block --><\/div> <!-- aio-icon-box --><\/div> <!-- aio-icon-component -->[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]<div class=\"aio-icon-component  vc_custom_1709813264879   style_1\"><div id=\"Info-box-wrap-7835\" class=\"aio-icon-box left-icon\" style=\"\"  ><div class=\"aio-icon-left\"><div class=\"ult-just-icon-wrapper  \"><div class=\"align-icon\" style=\"text-align:center;\">\n<div class=\"aio-icon-img \" style=\"font-size:150px;display:inline-block;\" >\n\t<img decoding=\"async\" class=\"img-icon\" alt=\"Cigniti receives the \u201c2023 Customer Value Leadership Award\u201d from Frost and Sullivan\" src=\"https:\/\/coforge.site\/cigniti_new\/wp-content\/uploads\/Frost-Sullivan-Award-2023.jpg\"\/>\n<\/div><\/div><\/div><\/div><div class=\"aio-ibd-block\"><div class=\"aio-icon-description ult-responsive\"  data-ultimate-target='#Info-box-wrap-7835 .aio-icon-description'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  style=\"\"><\/p>\n<p style=\"text-align: left; font-size: 16px !important; margin-bottom: 0px;\">Cigniti earns Frost &amp; Sullivan&#8217;s &#8220;2023 Customer Value Leadership Award&#8221; for outstanding Digital Engineering and Assurance services in global healthcare, showcasing best practices and achievements.<\/p>\n<p><\/div> <!-- description --><\/div> <!-- aio-ibd-block --><\/div> <!-- aio-icon-box --><\/div> <!-- aio-icon-component -->[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221;][vc_column width=&#8221;1\/2&#8243; section_text_color=&#8221;light&#8221; section_skin=&#8221;light&#8221;][vc_row_inner css=&#8221;.vc_custom_1600435802380{background-color: #2d3236 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column_inner el_class=&#8221;first-box&#8221; width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\n<h4>Channeling the Power of Automation in Medical Device Testing<\/h4>\n<p><a href=\"https:\/\/coforge.site\/cigniti_new\/blog\/automation-medical-device-testing\/\" target=\"_blank\" rel=\"noopener\" class=\"broken_link\">Read more<\/a>[\/vc_column_text][vc_column_text el_class=&#8221;blog-arrow3&#8243;]<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;first-box-2&#8243; width=&#8221;1\/2&#8243;]<div class=\"porto-image-frame  qes-img\"><span class=\"thumb-info thumb-info-hide-wrapper-bg\"><a href=\"\/blog\/automation-medical-device-testing\/\" title=\"\" target=\"_blank\"><span class=\"thumb-info-wrapper\"><img decoding=\"async\" alt=\"\" src=\"\/\/coforge.site\/cigniti_new\/wp-content\/uploads\/Channeling-the-Power-of-Automation-in-Medical-Device-Testing_Medical_Device_testing.png\" class=\"img-responsive\" width=\"t\" height=\"t\"><\/span><\/a><\/span><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_row_inner css=&#8221;.vc_custom_1709715754592{background-color: #078795 !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column_inner el_class=&#8221;first-box&#8221; width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<h4>10 Testing Recommendations for Software as Medical Device<\/h4>\n<p><a href=\"\/blog\/ten-testing-recommendations-software-as-medical-device\/\" target=\"_blank\" rel=\"noopener\" class=\"broken_link\">Read more<\/a>[\/vc_column_text][vc_column_text el_class=&#8221;blog-arrow2&#8243;]<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;first-box-2&#8243; width=&#8221;1\/2&#8243;]<div class=\"porto-image-frame  qes-img\"><span class=\"thumb-info thumb-info-hide-wrapper-bg\"><a href=\"\/blog\/ten-testing-recommendations-software-as-medical-device\/\" title=\"\" target=\"_blank\"><span class=\"thumb-info-wrapper\"><img decoding=\"async\" alt=\"\" src=\"\/\/coforge.site\/cigniti_new\/wp-content\/uploads\/medical-device-testing-blog.jpg\" class=\"img-responsive\" width=\"t\" height=\"t\"><\/span><\/a><\/span><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; bg_type=&#8221;bg_color&#8221; bg_override=&#8221;full&#8221; bg_color_value=&#8221;#605533&#8243;][vc_column width=&#8221;1\/2&#8243; section_text_color=&#8221;light&#8221; section_skin=&#8221;light&#8221;][vc_row_inner css=&#8221;.vc_custom_1596793520702{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column_inner el_class=&#8221;first-box&#8221;][vc_column_text]<\/p>\n<h4>Revolutionizing Diabetes Care: CGMs, Device Software, and the Journey to Safer Health Tech<\/h4>\n<p><a href=\"\/resource\/white-papers\/patient-safety-medical-device-testing-continuous-glucose-monitoring-devices\/\" target=\"_blank\" rel=\"noopener\">Read more<\/a>[\/vc_column_text][vc_column_text el_class=&#8221;blog-arrow1&#8243;]<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_row_inner css=&#8221;.vc_custom_1596793508477{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column_inner]<div class=\"porto-image-frame  qes-img\"><span class=\"thumb-info thumb-info-hide-wrapper-bg\"><a href=\"\/resource\/white-papers\/patient-safety-medical-device-testing-continuous-glucose-monitoring-devices\/\" title=\"\" target=\"_blank\"><span class=\"thumb-info-wrapper\"><img decoding=\"async\" alt=\"\" src=\"\/\/coforge.site\/cigniti_new\/wp-content\/uploads\/Revolutionizing-Diabetes-Care_WP.jpg\" class=\"img-responsive\" width=\"t\" height=\"t\"><\/span><\/a><\/span><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=&#8221;section-bg&#8221; css=&#8221;.vc_custom_1716974230595{padding-top: 25px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Medical Devices Testing services&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:left|color:%23000066|line_height:40px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text]Medical devices form a critical part of the <a href=\"https:\/\/coforge.site\/cigniti_new\/industries\/healthcare-software-testing-services\/\"><u>Healthcare &amp; Life Sciences industry<\/u><\/a> as they have a direct impact on the lives of patients. To deliver a superior and safe experience to patients, medical device manufacturers need to continuously innovate the devices with the help of software. However, with the benefits of software come the risk of defects and bugs. Medical device testing thus demands rich experience of the domain, local and federal legislations, knowledge of devices, infrastructure and capability to support the testing.<\/p>\n<p>We are an ISO13485:2016 Certified Organization &amp; the chosen Software Testing services partners for large Medical Device manufacturers and users. We help you address challenges in Medical device software testing and also in implementing guidelines &amp; best practices in software testing lifecycle of these devices.<\/p>\n<p class=\"x_MsoNormal\">Cigniti\u2019s dedicated Medical Devices Testing CoE experts help Verify &amp; Validate Software for surgical instruments, contact lenses &amp; ultrasound scanners, orthopaedic implants &amp; haemodialysis machines, cardiac pacemakers.<\/p>\n<div>\n<div>Our experts are fully capable of helping Clients test their smart, AI-based medical &amp; healthcare\u00a0devices such as Intelligent Beds, sterilization equipment, tool kits for Pets, etc.<\/div>\n<\/div>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row bg_type=&#8221;bg_color&#8221; bg_override=&#8221;full&#8221; bg_color_value=&#8221;#0093d9&#8243; el_class=&#8221;section-bg&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Cigniti\u2019s Medical Device Testing Center of Excellence&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:left|color:%23ffffff|line_height:Normal&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<strong style=\"color: white;\">Cigniti\u2019s Medical Devices Testing Center of Excellence provides the following unique values to multiple organizations:<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px; color: #fff;\">\n<li>Expertise in Verification &amp; Validation of Class I, Class II and Class III Medical Devices in the area of Diagnostics, Imaging, Orthopaedics, Surgical, Cardiology, and Dental<\/li>\n<li>Testing strategy to satisfy the demands of both the public and the regulatory bodies<\/li>\n<li>Expertise in Verification &amp; Validation of various Medical Devices<\/li>\n<li>Testing approach that matches test coverage to parameters that will reveal the defects most likely to occur<\/li>\n<li>Risk Based Testing using Design Failure Modes, Effects and Criticality Analysis (FMECA)<\/li>\n<li>In-house training &amp; certification for <u><a style=\"color: white;\" href=\"https:\/\/coforge.site\/cigniti_new\/industries\/healthcare-software-testing-services\/\">Healthcare and Life Sciences<\/a><\/u> Domain<\/li>\n<\/ul>\n<p style=\"color: white;\">It also provides the following expertise in Medical Device Testing:<\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px; color: #fff;\">\n<li>Quality Control Checks &#8211; Verifies Accuracy of Sample Analysis<\/li>\n<li>System Suitability Tests &#8211; Verifies System Performs according to Analysts Expectations<\/li>\n<li>Analytical Instrument Validation &#8211; Proof Suitability of the instrument for the intended use<\/li>\n<li>Analytical Method Validation &#8211; Proof that analytical procedure does what it purports to do<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=&#8221;section-bg&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Medical Device Testing Approach&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:left|color:%23000066|line_height:40px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]Cigniti follows a 5-step testing approach which is aligned with the development lifecycle enabling a better understanding of the test requirements. Our Risk-based approach to validate the hardware, software and Peripheral Devices Testing allows us to test user &amp; business requirements associated with the intended use of the system.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<strong>Analysis Phase<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Determine Medical devices in scope and regulatory compliance needs<\/li>\n<li>Finalize Test Methodology, Approach and Deliverables<\/li>\n<li>Validation Plan<\/li>\n<li>Document requirements<\/li>\n<li>Design qualification<\/li>\n<li>Risk assessment<\/li>\n<li>Impact assessment<\/li>\n<li>Validation Master Plan<\/li>\n<li>Communication Model<\/li>\n<li>Metrics framework<\/li>\n<\/ul>\n<p><strong>Design Phase<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Finalize Validation Plan<\/li>\n<li>Protocol development (IQ, OQ, PQ)<\/li>\n<li>Author Test cases\/Scripts<\/li>\n<li>Build Validation Approach<\/li>\n<li>Requirement Traceability matrix<\/li>\n<li>SOP development<\/li>\n<li>Colaborate with Client on test data equirements<\/li>\n<li>Validation Training<\/li>\n<li>Sign off from client<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<strong>Deployment Phase<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Smoke testing on the test environment<\/li>\n<li>Code \/ document reviews<\/li>\n<li>Perform test execution<\/li>\n<li>Execution of Verification and Validation documentation suit (for IQ, OQ, PQ)<\/li>\n<li>Defect Logging and Retesting<\/li>\n<li>Execution summary report<\/li>\n<li>Sign off from Client<\/li>\n<\/ul>\n<p><strong>Closure Phase<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Hardware and software Testexecution Summary Report<\/li>\n<li>Defect Summary Report<\/li>\n<li>Metrics and SLAs<\/li>\n<li>System Release GO\/No-Go Dashboard<\/li>\n<li>Best Practices and Lesson Learnt<\/li>\n<\/ul>\n<p><strong>Maintenance Phase<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Change control plan<\/li>\n<li>Change request<\/li>\n<li>Risk assessment<\/li>\n<li>Impact assessment<\/li>\n<li>Approval of change<\/li>\n<li>Implementation of change<\/li>\n<li>Re-validation of system as per requirements<\/li>\n<li>System release Go\/No-Go dashboard<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row bg_type=&#8221;bg_color&#8221; bg_override=&#8221;full&#8221; el_class=&#8221;section-bg&#8221; bg_color_value=&#8221;#f2f2f2&#8243;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Supported Regulations &amp; Compliances&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:left|color:%23000066|line_height:40px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]Regulations and Compliances particularly from the Food and Drug Administration (US FDA) plays an important role when it comes to Medical devices testing. We have expertise in testing highly regulated industrial sectors in United States, governed and directed by various state regulatory bodies &amp; federal regulatory authority.<\/p>\n<p>We conduct following types of testing to Verify and Validate Medical Systems and its Applications:[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/4&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][vc_column_text]<\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Lifecycle V&amp;V<\/li>\n<li>GUI Testing<\/li>\n<li>Performance Testing<\/li>\n<li>Non-GUI Testing<\/li>\n<li>Compliance Testing<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][vc_column_text]<\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Interoperability Testing<\/li>\n<li>Behaviour Testing<\/li>\n<li>Reliability Testing<\/li>\n<li>User Acceptance Testing<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row el_class=&#8221;section-bg&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Computer System Validation (CSV) &#8211; Model&#8221; font_container=&#8221;tag:h2|font_size:36px|text_align:left|color:%23000066|line_height:Normal&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:300%20light%20regular%3A300%3Anormal&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<strong>Cigniti practices a CSV model that helps provide the following services:<\/strong><\/p>\n<ul style=\"list-style-type: inherit; padding-left: 40px;\">\n<li>Validation approach aligned with development enabling better understanding of the test requirements<\/li>\n<li>Risk based approach to validate the Hardware, Software and Peripheral Devices<\/li>\n<li>Testing of the User &amp; Business requirements associated with the intended use of the system<\/li>\n<li>Equipped with the mandatory authentication checks for the regulatory compliances<\/li>\n<li>Functional and Timely verification across various components<\/li>\n<li>Through reporting for external and internal stakeholders<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row bg_type=&#8221;bg_color&#8221; bg_override=&#8221;full&#8221; el_id=&#8221;contact&#8221; bg_color_value=&#8221;#0c0a5a&#8221;][vc_column][vc_custom_heading text=&#8221;Contact Us&#8221; font_container=&#8221;tag:h2|text_align:center|color:%23ffffff&#8221; use_theme_fonts=&#8221;yes&#8221; el_class=&#8221;m-t-lg m-b-none&#8221;][vc_column_text css=&#8221;.vc_custom_1585645384765{padding-top: 12px !important;padding-bottom: 12px !important;}&#8221; el_class=&#8221;m-b-none&#8221;]<\/p>\n<p style=\"text-align: center; color: white;\">Consult our experienced team for Medical Device Testing services.<\/p>\n<p>[\/vc_column_text][vc_column_text]<iframe class=\"utm-src\" style=\"border: 0;\" src=\"https:\/\/engage.cigniti.com\/l\/914201\/2021-02-26\/fhr\" width=\"100%\" height=\"320\" frameborder=\"0\"><\/iframe>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;main-banner&#8221;][vc_column][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;Medical Device Testing Services&#8221; font_container=&#8221;tag:h1|font_size:41px|text_align:left|line_height:50px&#8221; google_fonts=&#8221;font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:600%20bold%20regular%3A600%3Anormal&#8221; css=&#8221;.vc_custom_1585659283311{margin-bottom: 15px !important;}&#8221;][vc_column_text] Verification &amp; Validation of Medical Devices used by Dentists, Surgeons, Ophthalmologists, Endocrinologists, &amp; Cardiologists such as surgical instruments, contact lenses &amp; ultrasound scanners, orthopedic implants &amp; hemodialysis machines, cardiac pacemakers, imaging, etc. [\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;section-bg&#8221;][vc_column][vc_custom_heading text=&#8221;Optimize medical device testing outcomes with [&hellip;]<\/p>\n","protected":false},"author":24,"featured_media":0,"parent":10472,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-8368","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/pages\/8368","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/comments?post=8368"}],"version-history":[{"count":0,"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/pages\/8368\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/pages\/10472"}],"wp:attachment":[{"href":"https:\/\/coforge.site\/cigniti_new\/wp-json\/wp\/v2\/media?parent=8368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}