0
100% Satisfaction Guarantee
Amazing Value
Fast Shipping
Expert Customer Service
生物材料的医疗器械转化
$47.16
本书描述了生物材料转化为医疗器械过程中方方面面的要点和注意事项,也描述了植入医疗器械临床试验研究、技术要求等内容,包括生物材料转化为医疗器械的选题、步骤和主要的环节。其中,步骤主要包括产品的分类、风险分析、送检过程及临床试验报告;主要环节包括办注册证、生产过程、销售过程和融资过程。在美国食品药品监督管理局(FDA)和欧盟认证(CE)注册证办理过程中,豁免临床试验的规定较明确,我国的相关规定还在发展中。
目录序前言第1章 植入医疗器械的开发选题 11.1 引言 11.2 市场需求 21.3 技术先进性和技术诀窍 31.4 注册风险 61.5 市场推广难度 6第2章 从生物材料技术到产品的转化过程 72.1 临床对产品需求的准确定义 72.1.1 如何发现需求 72.1.2 如何确定需求 82.2 从技术到产品 92.2.1 制定研发战略 92.2.2 依靠国家政策 102.3 医疗器械GMP车间的建设 112.3.1 GMP的基本概念 112.3.2 中国GMP的发展与历史 122.3.3 医疗器械GMP车间 122.3.4 医疗器械GMP车间的洁净度要求 132.3.5 医疗器械GMP车间的生产厂房建设 142.3.6 医疗器械GMP车间的净化空调系统建设 152.3.7 医疗器械GMP车间的水系统建设 172.4 产品的文件输出及验证 192.4.1 参考法规及标准 192.4.2 产品的设计开发程序 192.4.3 设计开发的策划 202.4.4 设计输入 212.4.5 设计开发阶段 212.4.6 设计转换 222.4.7 设计验证 222.4.8 设计输出 232.4.9 设计确认 232.4.10 产品注册 232.4.11 项目结题 242.4.12 设计开发变更 242.4.13 结语 252.5 产品生物学评价 252.5.1 医疗器械产品生物学评价的目的与意义 252.5.2 医疗器械生物学评价程序 262.5.3 医疗器械生物学评价原则 282.5.4 医疗器械生物学评价内容 302.5.5 医疗器械生物学评价结果的表现形式 302.6 动物试验研究 312.6.1 动物试验研究在医疗器械安全性评价中的意义 312.6.2 动物福利 322.6.3 动物试验 332.6.4 动物试验替代发展趋势 352.7 产品质量体系的建立 362.7.1 建立医疗器械质量管理体系的原因 362.7.2 质量管理体系简介 372.7.3 建立医疗器械质量管理体系的要点 382.7.4 企业如何建立医疗器械质量管理体系 392.7.5 结语 412.7.6 国内医疗器械质量管理体系相关的法规及标准 42第3章 植入医疗器械的技术要求 433.1 引言 433.2 产品技术要求制定的意义 443.3 产品技术指标的科学设定 463.3.1 相关医疗器械注册技术指导原则 473.3.2 相关产品标准 493.3.3 国内外药典 503.3.4 参考同类产品的相关技术指标 513.3.5 存在的问题 523.4 产品技术指标的验证 523.4.1 检验人员 533.4.2 检测仪器及辅助通用设备 533.4.3 检验样品 543.4.4 检测方法 54第4章 植入性医疗器械的临床研究 564.1 临床试验基础 564.1.1 做临床试验的原因 564.1.2 需要做临床试验的医疗器械 574.1.3 临床试验的流程 574.2 临床试验设计 614.2.1 临床试验设计的方法 614.2.2 临床试验设计中的注意事项 674.3 临床试验的质量控制 684.3.1 始于试验设计 684.3.2 重在过程控制 694.3.3 终于契合临床的结果分析报告 714.4 临床试验策略 714.4.1 临床试验的开始 714.4.2 关注法规动态 724.4.3 从试验中获取更多 72第5章 产品的注册或认证 735.1 国家药品监督管理局对植入器械的注册要求 735.1.1 国家药品监督管理局的历史沿革及简介 735.1.2 我国的医疗器械法规体系 745.1.3 上市许可持有人简介 875.1.4 上市前注册申报流程简介(国产三类器械) 905.1.5 上市前注册申报资料要求 915.1.6 第三类高风险医疗器械临床试验审批申报资料要求 1055.1.7 创新医疗器械特别审批/医疗器械优先审批程序简介 1065.1.8 创新医疗器械申报资料要求 1085.2 国内植入器械创新产品的案例分析 1115.2.1 案例1:仿生矿化胶原人工骨(骼金) 1115.2.2 案例2:首个国产人工真皮(Lando?) 1155.3 欧盟医疗器械法规/CE认证 1175.3.1 欧盟医疗器械法规 1175.3.2 欧盟医疗器械市场准入 1195.3.3 欧盟新的医疗器械法规 1205.4 美国医疗器械法规 1215.4.1 FDA简介 1215.4.2 美国医疗器械的监管 122第6章 新产品的市场分析和推广 1286.1 新产品的市场分析 1286.1.1 医疗器械市场的概念 1286.1.2 医疗器械市场的选择 1286.1.3 市场需求的影响因素 1296.2 产品学术推广 1296.2.1 学术推广的四要素 1306.2.2 学术推广的形式 1316.2.3 学术推广的意义 132第7章 医疗器械技术与资本的有机结合 1347.1 技术转化对资金需求的预测 1347.2 融资攻略 1357.2.1 商业计划书 1357.2.2 融资渠道 136参考文献 138
Shipping Overview:
• Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99.
• Order Processing: Please allow 1-2 business days for order processing and preparation before shipment.
• Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days.
• International Shipping: Currently, we only ship within the USA.
• Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.
Shipping Delays:
Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.
Shipping Options:
Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.
Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.
Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.
Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.
Delivery Details:
Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.
Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.
Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.
Shipping Confirmation:
You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.
Order Modifications:
If you need to cancel or modify your order, please contact our customer support immediately.
Issues with Delivery:
If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.
Customer Support:
Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.
Return & Refund Policy Overview
Please review our return and refund policies below to ensure a smooth transaction process.
Return Policy
Duration: You have 30 days from receiving your item to initiate a return.
Condition: Items must be unworn, unwashed, with original tags and packaging intact.
Shipping Costs: Customers are responsible for return shipping costs.
Packaging: Ensure returned items are well-packaged to avoid damage during transit.
Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.
Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.
How to Return
Method: Returns must be sent back by mail to the address provided in the return instructions.
Return Label
Defective Products: Return labels are provided for defective items.
Non-Defective Returns: Customers are responsible for obtaining their return shipping label.
Product Conditions for Return
Eligible Products: Returns are only accepted for items in new condition.
Nonreturnable Items
Certain items are not eligible for return:
Electronic devices after 30 days (e.g., computers, laptops, Kindles)
Gift cards, prepaid game cards
Perishable goods, live insects, some jewelry, some health and personal care items
Customized or personalized products
Items with special shipping restrictions
Refund Policy
Window: Eligible products may be returned within 30 days of delivery for a refund.
Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.
Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.
Claims
Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.
Exchange Policy
For the quickest service, return your original item and place a new order for the desired product once your return is accepted.
Return Address
EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366
Customer Support
Available 24/7 for any questions or assistance needed:
Phone: +1 636-312-5925
Email: cs@everymarket.com
Oops!
Sorry, it looks like some products are not available in selected quantity.
OK