{"id":127733,"date":"2025-07-01T15:57:07","date_gmt":"2025-07-01T13:57:07","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?p=127733"},"modified":"2026-04-02T12:04:38","modified_gmt":"2026-04-02T10:04:38","slug":"why-medical-device-is-basically-rocket-science","status":"publish","type":"post","link":"https:\/\/lightweb.dev\/s\/key2compliance\/blog\/why-medical-device-is-basically-rocket-science\/","title":{"rendered":"Why Medical Device is basically Rocket Science"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Afifa\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Nadia Ragnvald Caspersen
Senior consultant, QA\/RA – GBA Key2Compliance<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t

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\u201cWe choose to go to the moon\u2026 not because it is easy, but because it is hard.\u201d<\/em>\u202f\u00a0(John F. Kennedy)
<\/i>– Honestly, he could\u2019ve been talking about bringing a medical device to market.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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It\u2019s hard. It\u2019s expensive. It\u2019s regulated to the moon and back. But it\u2019s also one of the most rewarding things you can do\u2014if you know what you\u2019re doing (or at least know who to ask).\u00a0<\/p>

In this article, I\u2019ll be sharing the\u202f6 key phases\u202fthat every MedTech startup needs to navigate. Think of it as a roadmap for turning your brilliant idea into a compliant, fundable, launch-ready product\u2014with fewer surprises and more investor nods.\u00a0<\/p>

Whether you’re building your first prototype or pitching your Series A, this article is for you.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Phase 1: Regulatory & Business Strategy
\n\u2013 Mission Planning Complete. Standing by for systems check.<\/i><\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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So, you\u2019ve got a brilliant idea for a medical device? That\u2019s fantastic! But before you start sketching prototypes or dreaming of changing the world (or at least getting your first clinical study underway), let\u2019s talk about the\u202fvery first\u202f(and arguably most important) phase: aligning your\u202fregulatory pathway\u202fwith your\u202fbusiness strategy.\u00a0<\/p>

This isn\u2019t just paperwork\u2014it\u2019s your\u202flaunchpad. And yes, it\u2019s where many startups either set themselves up for success\u2026 or for a very expensive detour.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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What\u2019s the Goal? <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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To build a solid foundation by ensuring your product is\u202fviable,\u202fcompliant, and\u202ffundable. Think of it as your MedTech GPS: if you don\u2019t know where you\u2019re going, how will you convince investors to come along for the ride?\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Key Activities: <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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  1. Define the Business Objective\u00a0<\/strong>
    What problem are you solving? Who cares about it? And why should they pay for it?<\/li>
  2. Market & Reimbursement Strategy\u00a0<\/strong>
    EU? US? UK? Mars? (Okay, maybe not Mars\u2014yet.)
    Understand where your product fits and how it gets paid for.<\/li>
  3. Product Qualification\u00a0<\/strong>
    Is it even a medical device? (Spoiler: not everything with a battery and a heartbeat monitor is.)<\/li>
  4. Device Classification & Regulatory Pathway\u00a0<\/strong>
    Class I, IIa, IIb, III, A, B, C, D\u2014these classifications aren\u2019t just labels; they define the regulatory expectations for your product. Whether you’re developing a medical device or an IVD, your classification determines the level of scrutiny, the documentation required, and whether a Notified Body needs to be involved.
    Pro tip: <\/i><\/strong>Getting this right early on is critical. It shapes your development timeline, budget, and even your investor pitch. It\u2019s not just a regulatory step\u2014it\u2019s a strategic cornerstone.<\/li>
  5. Competitor & Regulatory Landscape Analysis
    <\/strong>What are others doing? And how can you do it smarter?<\/li>
  6. Regulatory Readiness Checklist<\/strong>
    Intended use, patient population, use environment\u2014yes, it\u2019s a checklist, but it\u2019s also your risk radar. Use it to ensure all internal, external, and product-specific factors are considered before moving forward.<\/li>
  7. Leadership & Funding Alignment<\/strong>
    A clear regulatory roadmap = a compelling pitch deck. Investors love clarity.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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    Milestones: <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tBusiness case and market prioritization approved <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tRegulatory Strategy documented <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tDevice classification confirmed <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tInitial funding secured <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tRegulatory checklist completed and signed off <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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      Why This Matters for Startups: <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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      Many startups underestimate the\u202ftrue cost\u202fof bringing a device to market. When you hear the full number up front, it can feel like someone just dropped a defibrillator on your budget. But when you break it down\u2014phase by phase\u2014it becomes manageable, strategic, and even\u2026 exciting?\u00a0<\/p>

      And remember: all that documentation? It\u2019s not just red tape. It\u2019s\u202fvalue. It\u2019s\u202fIP. It\u2019s what turns your napkin sketch into a fundable, scalable business.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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      Phase 2: Regulatory Planning & Market Intelligence
      \n\u2013 All Systems Go for Launch Configuration.<\/i><\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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      You\u2019ve got your regulatory strategy in place\u2014great start! Now it\u2019s time to roll up your sleeves and turn that strategy into a\u00a0concrete, actionable plan. This phase is all about\u00a0planning smart\u00a0and\u00a0knowing your markets\u00a0so you can avoid surprises later (the bad kind, not the birthday cake kind).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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      What\u2019s the Goal? <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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      Translate your high-level regulatory strategy into a detailed plan and gather the intelligence you need to navigate your target markets with confidence.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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      Key Activities:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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      1. Develop the Regulatory Plan<\/strong>
        Use the output from Phase 1 to build a structured plan that includes:
        • Device description and intended purpose<\/li>
        • Risk classification and justification<\/li>
        • Applicable legal requirements and standards<\/li>
        • Conformity assessment route<\/li>
        • Roles, responsibilities, and required competencies<\/li>
        • Timeline and cost estimates


          Pro tip:<\/strong> \u202fDon\u2019t stop at the medical regulations. Have you looked one layer deeper? Your product might also fall under rules related to materials, electronics, environmental impact, or other sector-specific legislation. Identifying these early can save you from costly surprises later.<\/i><\/p><\/li><\/ul><\/li>

        • Select Notified Body (if applicable)<\/strong>
          • Is a Notified Body required based on your classification?<\/li>
          • Are they designated and authorized for the relevant regulatory frameworks (e.g., MDR, IVDR, or other applicable legislation)?<\/li>
          • Are they accepting new clients\u2014and do they have time for you?<\/li><\/ul><\/li>
          • Market-Specific Regulatory Intelligence<\/strong>
            Prioritize countries based on your business strategy and regulatory complexity. For each market, identify:
            • Local regulatory authorities (e.g., MHRA, Swissmedic)<\/li>
            • Registration processes and timelines<\/li>
            • Language and translation requirements<\/li>
            • Mutual recognition or reliance on other approvals (e.g., FDA, CE)<\/li><\/ul><\/li>
            • Identify Economic Operators<\/strong>
              Define and document roles for:
              • Manufacturer<\/li>
              • Authorized Representative (AR)<\/li>
              • Importer<\/li>
              • Distributor

                Pro tip: <\/strong>Make sure contracts and communication channels are in place.<\/em><\/li><\/ul><\/li>
              • Resource Planning\u00a0<\/strong>
                Estimate the internal and external resources you\u2019ll need:
                • \u00a0Regulatory consultants<\/span>\u00a0<\/li>
                • Clinical experts<\/li>
                • Technical writers


                  Pro tip: <\/strong>Confirm availability and qualifications early\u2014it saves headaches later.<\/em><\/p><\/li><\/ul><\/li>

                • Regulatory Readiness Checklist<\/strong>
                  Ensure your Regulatory Plan is documented, version-controlled, and integrated into your QMS. Plan for regular updates and reviews\u2014it\u2019s a living document, not a one-time task.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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                  Milestones:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tRegulatory Plan finalized and approved<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tNotified Body engagement confirmed (if applicable)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tMarket-specific regulatory requirements documented<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tEconomic operators identified and agreements initiated<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tResource plan and budget approved<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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                    Why This Matters for Startups<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                    This is where your strategy becomes reality. Without a clear plan, even the best ideas can stall. And while it might feel like a lot of admin, this phase is what gives your project structure, direction, and credibility\u2014especially when talking to investors or partners.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                    Phase 3:Product Development & QMS Implementation
                    \n\u2013 Fueling Complete. Final Systems Integration Underway.<\/i><\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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                    Now that your regulatory plan is in place, it\u2019s time to bring your product to life\u2014on paper, in the lab, and in your quality system. This phase is where design meets discipline: you\u2019re not just developing a device, you\u2019re building the systems that will support it all the way to market (and beyond).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                    What\u2019s the Goal? <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                    Design and develop your medical device while implementing a\u00a0compliant Quality Management System (QMS)\u00a0that supports both regulatory and product requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                    Key Activities:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                      \n \t
                    1. Finalize Design Inputs<\/strong>\nTranslate user needs and regulatory requirements into clear, testable design inputs:\n
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                      • Functional, performance, and safety requirements<\/li>\n \t
                      • Aligned with intended use and risk classification<\/li>\n<\/ul>\n<\/li>\n \t
                      • Risk Management\n<\/strong>Develop a risk management plan (hello, ISO 14971!) and keep it alive throughout development:\n
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                        • Identify hazards<\/li>\n \t
                        • Evaluate and control risks<\/li>\n \t
                        • Maintain a risk management file<\/li>\n<\/ul>\n<\/li>\n \t
                        • Prototype Development & Verification<\/strong>\nTime to get hands-on:\n
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                          • Build and test prototypes<\/li>\n \t
                          • Conduct bench testing, usability studies, and simulations<\/li>\n \t
                          • Document everything\u2014if it\u2019s not written down, it didn\u2019t happen<\/li>\n<\/ul>\n<\/li>\n \t
                          • QMS Implementation (ISO 13485)<\/strong>\nSet up a QMS that fits your product and your team:\n
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                            • SOPs for design, document control, supplier management, complaints and CAPA<\/li>\n \t
                            • Assign a Person Responsible for Regulatory Compliance (PRRC) if required (e.g., under EU MDR\/IVDR)<\/li>\n<\/ul>\n<\/li>\n \t
                            • Supplier Evaluation & Control\u00a0<\/strong>\nYour product is only as strong as your supply chain:\n
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                              • Identify critical suppliers<\/li>\n \t
                              • Assess compliance<\/li>\n \t
                              • Set up quality agreements and audit plans<\/li>\n<\/ul>\n<\/li>\n \t
                              • Design Reviews<\/strong>\nDon\u2019t skip the checkpoints:\nIdentify critical suppliers\nAssess compliance\nSet up quality agreements and audit plans<\/li>\n
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                                • Conduct formal reviews at key stages<\/li>\n
                                • Include cross-functional input (R&D, QA\/RA, clinical, etc.)<\/li>\n
                                • Document decisions and actions<\/li>\n<\/ul>\n<\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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                                  Milestones:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tDesign inputs and risk management plan approved<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tFirst prototype developed and verified<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tQMS implemented and documented<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tSOPs established and PRRC assigned (if applicable)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tSupplier evaluation completed<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
                                  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tDesign review(s) conducted and documented<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
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                                    Why This Matters for Startups:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                                    This is where your idea becomes real\u2014and where regulators start paying close attention. A solid QMS isn\u2019t just a compliance checkbox; it\u2019s your\u00a0operational backbone. And trust me, future you (and your investors) will thank you for getting it right early.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                                    Phase 4: Clinical Evaluation & Technical Documentation
                                    \n\u2013 T-minus Zero: Go for Launch<\/i><\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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                                    You\u2019ve built it. Now it\u2019s time to prove it\u2019s safe, it works, and you\u2019ve got the paperwork to back it up. This phase is where clinical evidence meets documentation discipline\u2014and yes, it\u2019s as important as it sounds.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                                    What\u2019s the Goal? <\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                                    Generate the necessary clinical evidence and compile the technical documentation required for regulatory approval\u2014whether you’re aiming for CE marking, FDA clearance, or another market entry.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                                    Key Activities:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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                                    1. Clinical Evaluation<\/strong>
                                      Conduct a Clinical Evaluation in line with regulatory expectations:
                                      • Use data from literature, clinical investigations (if needed), and equivalent devices<\/li>
                                      • Demonstrate safety and performance (or analytical and clinical performance for IVDs)<\/li>
                                      • Prepare a Clinical Evaluation Report (CER)\u2014or a Performance Evaluation Report (PER) if you’re working with an in vitro diagnostic (IVD).
                                        (Think of PER as the IVD cousin of CER\u2014same purpose, different focus.)<\/li><\/ul><\/li>
                                      • Clinical Investigation (if applicable)
                                        <\/strong>If your device needs fresh clinical data:
                                        • Plan and conduct a clinical investigation<\/li>
                                        • Obtain ethics and regulatory approvals<\/li>
                                        • Monitor and report adverse events<\/li>
                                        • Document everything (yes, again)<\/li><\/ul><\/li>
                                        • Compile Technical Documentation<\/strong>
                                          Structure your documentation to meet the requirements of your target market:
                                          • Device description and specifications<\/li>
                                          • Design and manufacturing information<\/li>
                                          • Risk management documentation<\/li>
                                          • Verification and validation data<\/li>
                                          • Labeling and instructions for use<\/li>
                                          • Clinical Evaluation Report (CER) or PER<\/li>
                                          • Post-market surveillance or performance follow-up plans<\/li>
                                          • General safety and performance requirements (or equivalent, depending on region)<\/li><\/ul><\/li>
                                          • Prepare for Regulatory Review<\/strong>
                                            • Ensure everything is complete, consistent, and review-ready<\/li>
                                            • Submit to a regulatory authority or notified body (if required)<\/li>
                                            • Be ready to respond to questions or non-conformities


                                              Pro tip:<\/strong> This phase isn\u2019t just about ticking boxes\u2014it\u2019s about building trust. Your technical documentation is what regulators, partners, and future auditors will rely on. Make it clear, complete, and compelling.<\/em><\/p><\/li><\/ul><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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                                              Milestones:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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