医疗器械EU MDR合规加速

OpenSOTA项目深知您在满足欧盟医疗器械法规 (EU MDR) 临床评价要求时面临的挑战。为此，我们特别推出限时限量推广活动，以空前优惠助力您的产品合规之路！

🗓️ 活动期限： 2025年6月1日 – 2025年12月31日

🎁 核心优惠套餐：

• 全套核心文档： 临床评价计划 (CEP) + 临床评价报告 (CER)，包含支持性的文献检索计划 (LSP) 和数据收集报告 (DCR)。
• 震撼推广价： 仅需人民币 ￥25000 ！
• 闪电交付： 平均仅需 1 周！ (从收到付款且客户按要求提供全部所需合格资料之日起计算，且约定范围的文献检索在筛选前不超过1000篇。)
• 珍稀名额： 全球仅限45个临床评价项目，先付先得，额满即止！

💡 为什么选择OpenSOTA本次推广？

• AI驱动，高效精准： 依托OpenSOTA先进的AI辅助文献检索与分析能力，显著提升SOTA总结及报告撰写效率与质量。
• 极致性价比： 以极具竞争力的价格，获得符合MDR基本要求的关键临床评价文档。
• 赢在起跑线： 快速完成合规文档，为您的产品争取宝贵的上市时间。
• 共建共享： 您项目中的通用SOTA成果（匿名化处理后）将助力OpenSOTA平台，惠及更广泛的行业同仁。

⚠️ 服务重要前提与客户协作须知 (请务必仔细阅读)：

为确保我们能高效、高质量地在承诺期内完成服务，您的理解与配合至关重要：

1. 文献检索范围：
   • 为实现1周快速交付，本服务要求双方商定的文献检索策略执行后，初步文献检索结果（正式筛选前）不超过1000篇。若超出，可能需要双方协商调整产品评价范围或探讨其他服务方案。
   • 您提供的产品信息（尤其是预期用途）需清晰、准确，以利于精准界定检索范围。
2. 等同论证资料 (如适用)：
   • 若宣称等同，您需提供等同器械的详细技术信息（如含技术参数的IFU、可验证的对照测试报告、或其他证明文件）。
     请注意：等同论证的强度高度依赖于您所提供资料的充分性、准确性和可比性。
3. 自有临床数据 (如适用)：
   • 若使用自有临床试验数据，请提供完整的临床试验报告 (CIR) 或已发表的研究文献。
4. 产品信息与适用标准：
   • 您需自行准确填写或最终确认待评价产品的详细信息（名称、型号、预期用途、适用人群、适应症、禁忌症、警告注意事项、工作原理等）及适用的相关标准清单。
     请注意：资料的及时、完整、准确提供是保障项目顺利启动和按时交付的基础。
5. SOTA内容公开同意：
   • 您同意，本项目中形成的关于临床背景信息 (Clinical Background) 及技术发展最新水平 (State-of-the-art, SOTA) 的通用性、非产品特异性总结内容，在经过匿名化和整合处理后，将作为公开信息贡献给OpenSOTA项目 (https://reguverse.com/documentation/state-of-the-art/)，遵循其现有公开原则，促进知识共享。我们将严格保护您的商业敏感信息（如具体产品设计、未公开数据等）。

🎯 谁最适合本推广？

• 具有清晰预期用途和技术路线的医疗器械。
• 能够提供充分、准确的等同器械信息或自有临床数据的企业。
• 寻求快速、经济高效的基础CEP/CER文档解决方案的企业。
• 认同OpenSOTA知识共享理念的企业。

🚀 立即行动，锁定名额！

1周交付时间从收到预定付款且您已按上述要求提供了全部所需且合格的基础资料之日开始计算，如遇不同项目在同一天付款且提供合格基础资料的情况，则按照提交申请的先后顺序进行交付。任何因客户方资料延迟、不完整或不准确导致的延误，交付周期将相应顺延。

名额有限，以完成付款及资料初步审核通过的顺序确认为准。

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🎉 Accelerate Your Medical Device’s EU MDR Compliance Journey! 🎉

At OpenSOTA, we understand the challenges of meeting the EU Medical Device Regulation (EU MDR) clinical evaluation requirements. That’s why we’re launching a limited-time, limited-quantity promotional offer to support your product’s path to compliance with unprecedented value!

🗓️ Promotion Period: June 1, 2025 – December 31, 2025

🎁 Core Offer Package:

• Full Core Documentation: Clinical Evaluation Plan (CEP) + Clinical Evaluation Report (CER), including supporting Literature Search Protocol (LSP) and Data Collection Report (DCR).
• Stunning Promotional Price: Only $3500 USD!
• Lightning-Fast Delivery: Average turnaround of just 1 Week! (Calculated from the date of payment receipt AND client’s provision of all required, complete, and accurate information, and contingent upon the initial literature search (pre-screening) under the agreed scope yielding no more than 1000 articles.)
• Exclusive & Limited: Only 45 clinical evaluation project slots available globally! First come, first paid, first served.

💡 Why Choose OpenSOTA for This Promotion?

• AI-Driven Efficiency & Precision: Leverage OpenSOTA’s advanced AI-assisted literature search and analysis capabilities for significantly enhanced SOTA summarization and report writing efficiency and quality.
• Ultimate Cost-Effectiveness: Obtain crucial clinical evaluation documents meeting fundamental MDR requirements at an exceptionally competitive price.
• Gain a Competitive Edge: Get your compliance documentation completed quickly, securing valuable time-to-market for your product.
• Contribute & Share: Anonymized, general SOTA findings from your project will enrich the OpenSOTA platform, benefiting the wider industry.

⚠️ Important Service Prerequisites & Client Collaboration (Essential Reading):

To ensure we can deliver high-quality service efficiently within the promised timeframe, your understanding and cooperation are crucial:

1. Literature Search Scope:
   • To achieve the 1-week rapid delivery, this service requires that the initial literature search results (before formal screening), based on the mutually agreed search strategy, do not exceed 1000 articles. If this threshold is surpassed, we may need to discuss adjusting the product evaluation scope or explore alternative service options.
   • Clear and accurate product information (especially intended purpose) provided by you is vital for precise search scope definition.
2. Equivalence Data (if applicable):
   • If claiming equivalence, you must provide detailed technical information for the equivalent device(s) (e.g., IFU with technical specifications, verifiable comparative test reports, or other substantiating documents).
     Please note: The robustness of the equivalence argument heavily depends on the sufficiency, accuracy, and comparability of the data you provide.
3. Own Clinical Data (if applicable):
   • If using your own clinical investigation data, please provide the full Clinical Investigation Report (CIR) or published research literature.
4. Product Information & Applicable Standards:
   • You are responsible for accurately providing or finally confirming the detailed information of the device under evaluation (name, model, intended purpose, target population, indications, contraindications, warnings, precautions, principle of operation, etc.) and the list of applicable relevant standards.
     Please note: Timely, complete, and accurate provision of this information is fundamental to project initiation and on-time delivery.
5. Consent for SOTA Content Publication:
   • You agree that general, non-product-specific summary content related to the Clinical Background and State-of-the-art (SOTA) developed during this project will, after anonymization and aggregation, be contributed as public information to the OpenSOTA project (https://reguverse.com/documentation/state-of-the-art/), adhering to its existing publication principles, to foster knowledge sharing. Your commercially sensitive information (e.g., specific product designs, unpublished data) will be strictly protected.

🎯 Who is This Promotion Best Suited For?

• Medical devices with a clearly defined intended purpose and technological basis.
• Companies capable of providing sufficient and accurate equivalent device information or their own clinical data.
• Companies seeking a rapid, cost-effective solution for foundational CEP/CER documentation.
• Companies that align with OpenSOTA’s knowledge-sharing philosophy.

🚀 Act Now to Secure Your Slot!

The 1-week delivery timeline commences from the date of aggred payment receipt AND your provision of all required, complete, and satisfactory baseline information as detailed above. If different projects pay and provide qualified baseline information on the same day, delivery will be made in the order of submission of applications.

Any delays due to late, incomplete, or inaccurate information from the client will result in a corresponding extension of the delivery period.

Slots are strictly limited and will be confirmed on a first-paid, first-served basis, subject to initial documentation review.