广东金石医疗科技服务有限公司 KINGROCK MEDICAL 安全 · 有效 · 合规 SAFETY · EFFECTIVENESS · COMPLIANCE

ENTERPRISE INTRODUCTION 公司介绍 广东金石医疗科技服务有限公司成立于2020年1月，总部位于粤港澳大湾区广州市黄埔区。我们汇聚了国内 外深耕医疗器械服务领域数十载的高精尖专家团队，配备按国际质量体系（GLP）要求与标准建造的实验室及 操作设备，为高端、创新型医疗器械企业提供整合、专业的技术服务。 KINGROCK was established in January 2020 with its headquarters in Guangzhou, China. We have been deeply involved in the field of medical device service for decades. We bring together an international expert team with extensive industrial experience, equipped with GLP laboratories built according to the highest quality system requirements and international standards. We always consider client services as our core value with professional technical services for the whole industrial chain of medical devices. 2000m+2 1500+ 150+ 50+ I期实验室 GLP项目数量 注册+CER 临床项目经验 Phase I Laboratory GLP Projects Registration+CER Clinical Projects 愿景/使命 VISION AND MISSION 我们致力于为全世界每一位病人 We are committed to bringing safe，effective 带去安全、有效、合规的医疗器械 我们旨在与合作伙伴密切协作 and compliant medical devices to every patient in 依托于整合的专家资源和无与伦比的专业知识 the world 为创新产品开发、优化、定制解决方案 We aim to work closely with our partners relying on integrated expert resources and unparal- leled expertise develop, optimize and customize solutions for inno- vative products 1

金石服务 项目综合管理新模式 KINGROCK SERVICE STRATEGIC PROGRAM INTEGRATED MANAGEMENT 金石医疗的服务贯穿医疗器械产品开发的全生命周期，作为 华南地区独有的集高端医疗器械GLP动物实验室、注册咨 询、临床研究与培训服务为一体的综合性服务平台，为全球 医疗器械研发生产企业提供全方位、一体化的解决方案，助 推高端医疗器械安全有效、快速合规地上市！ We provide medical device manufacturers with unparal- leled top-quality services, including biocompatibility testing, preclinical performance testing in vivo, clinical research, international registration consultancy, customized quality and technical trainings, etc to help them get their products into the market in the shortest time and in the most cost effective way. 实验室服务 临床研究 LABORATORY SERVICES CLINICAL RESEARCH 临床前大动物实验 Preclinical Studies 临床试验 Clinical Trials 生物相容性测试 Biocompatibility Testing · 项目管理 Project Management 生物学风险评估 Biological Risk Assessment · 数据管理 Data Management 临床前测试方法及模型建立 · 统计 Statistics Preclinical Research \& Model Development · 医学撰写 Medical Writing 临床评价报告 Clinical Evaluation Report 国际法规注册咨询 定制化培训 REGISTRATION CONSULTING CUSTOMIZED TRAINING 法规策略 Regulatory Strategy 注册申报策略 Registration and Declaration Strategy 法规递交 Regulation Submission 质量体系 Quality System 质量体系 Quality System 临床前研究 Preclinical Study 上市前后支持 医师培训等 Physician Training , etc. Support for the Products Pre and Post Entering the Market 2

临床前大动物实验PRECLINICAL STUDIES 临床前大动物实验可为医疗器械能否用于人体研究提供支持。通过相关动物模型来考察产品的安全 性和有效性，以及临床相关参数的确定，预测其在人群中使用时可能出现的不良事件，降低临床试验 受试者和临床使用者承担的风险，并为临床试验方案的制定提供依据及参考。 Preclinical studies can provide support whether medical devices can be used in human research. Through animal models and the determination of clinical parameters, the possi- ble adverse events were predicted when it was used in the population, so as to reduce the risk of clinical trial subjects and clinical users, and provide basis and reference for the formulation of clinical trial protocol. 我们为各类植介入医疗器械提供定制化临床前大动物疗效及性能实验 CUSTOMIZED EFFICACY AND PERFORMANCE 冠状动脉及外周血管支架、PTCA 导管和球囊，心脏瓣膜（主动脉瓣置换） Coronary artery and peripheral vascular stent, PTCA catheter, heart valve (aortic valve replacement) 补片类器械、骨科 / 听力植入器械、人工晶状体 (IOL)、生物可降解手术网、生物可降解聚合物薄膜、可降解手术缝合线 Patch, orthopedic / hearing implant device, intraocular lens (IOL), biodegradable surgical nets, biodegradable polymer films, degradable surgical sutures 体外循环系统及导管、血液成分分离器、血液透析导管及透析液，血管造影包和溶液、腹膜透析盒、止血材料、各种血袋 Extracorporeal circulation system and catheter, blood component separator, hemodialysis catheter and dialysate, angiography bag and solution, peritoneal dialysis box, hemostatic material, blood bag 脱细胞类器械（SIS 相关产品、人工角膜、神经修复材料、软骨修复材料，尿道修复材料等）、生物羊膜和部分胶原类器械（胶原缝合线和补片类） Decellularized devices (SIS related products, artificial cornea, nerve repair material, cartilage repair material, urethral repair material, etc.), biological amniotic membrane and some collagen devices (collagen suture and patch) 内窥镜产品、气管造口管、各种伤口敷料、眼科用器械等 Endoscope, tracheostomy tube, wound dressing, ophthalmic instrument 实验模型 IN VIVO MODEL 呼吸科 Respiratory 骨科 Orthopedics · 呼衰模型 Respiratory Failure Model · 骨折模型 Fracture Model · ARDS 模型 ARDS Model · 骨缺损模型 Bone Defect Model 心血管 Cardiovascular · 高血压模型 Hypertension Model · 动脉粥样硬化模型 Atherosclerosis Model · 心衰模型 Heart Failure Model · 动脉瘤模型 Aneurysm Model · 心梗模型 Myocardial Infarction Model · 血栓模型 Thrombosis Model · 心肌缺血再灌注损伤模型 Myocardial Ischemia-Reperfusion Injury Model · 二尖瓣狭窄模型 Mitral Valve Stenosis Model · 二尖瓣关闭不全模型 Mitral Valve Insufficiency Model 其他 Others · 硬脑膜缺损模型 Dural Defect Model · 角膜化学烧伤模型 Corneal Chemical Burn Model · 肾衰 Renal Failure Model · 尿道缺损模型 Urethral Defect Model 3

临床研究CLINICAL RESEARCH 临床研究阶段对医疗器械产品的成功开发至关重要。一方面，通过临床试验，医疗器械的安全性 和有效性得到合理评估，为医疗器械上市提供科学依据；另一方面，临床试验耗时长，花费多， 如果管理不当，有可能增加社会成本，给生产企业甚至消费者带来沉重的经济负担，进而影响医 疗器械行业的发展。 Clinical research is very important to the successful development of medical devices. Through clinical trials, the safety and effectiveness of medical devices can be reason- ably evaluated, which provides scientific basis for medical devices launch; on the other hand, clinical trials are time-consuming and costly. It may increase social cost and bring heavy economic burden to manufacturers and even consumers If not properly man- aged, thus affecting the development of the medical device industry. 临床研究服务范围 CLINICAL RESEARCH SERVICE SCOPE 医学撰写与医学支持 临床项目管理 Medical Writing and Support Project Management 数据管理 临床监查 Data Management Clinical Monitoring 统计分析 人员外派 Statistics Outsourcing 稽查与培训 Audit and Training 临床试验研究领域 THERAPEUTIC FIELD 心血管 伤口护理 神经 普通外科 骨科 口腔 眼科 Cardiology Wound Care Neurology Plastic Surgery Orthopedics Dental Ophthalmology 4

国际法规注册服务 INTERNATIONAL REGULATORY REGISTRATION SERVICE 金石医疗为准备进入市场的医疗器械与体外诊断生产企业提供专业的国内及海外注册咨询服务。 我们同海外资深顾问及专业咨询团队有着密切良好的合作。凭借金石团队与合作伙伴长期的国际注册经验，为您的产品提供合理的上市策 略分析、以及方式多样的注册预案。同时我们配备国内法规专家作为桥梁，协助您处理语言沟通及中西方文化差异的问题。如果您的产品想 进军海外市场或进行国内注册，您都可以在金石医疗找到合适的定制化服务。 KINGROCK medical provides professional medical device registration services for medical device and in vitro diagnostic reagent manufacturers preparing to enter the overseas market. We have good cooperation with overseas and foreign experts and professional consulting team. With the long-term international registration experience with our partners, we can provide you the reasonable market strategy and various registration plans for your products. At the same time, we have domestic regulatory experts as a bridge to help you deal with language communication problems and cultural differences between China and the West. If your products want to enter the overseas market or domestic registration, you can find appropriate professional services in KINGROCK . 国际注册咨询 法规服务 INTERNATIONAL REGISTRATION CONSULTING REGULATORY SERVICES 国际注册策略 上市前批准 Pre-Marketing Approval Global Regulatory Strategy \& Assessment 上市前通告 510 (k) Pre-Marketing Announcement 递交前会议 CE 标记 CE Mark Pre-Submission Meetings 产品风险等级的重新分类 质量体系及质量管理 Reclassification of De Novo Product Risk Levels Quality Systems / Quality Management 临床试验豁免申请 IDE Clinical Trial Exemption Application 临床评价报告 CER 器械豁免申请 IDE Submissions 进口/国产医疗器械注册 FDA 核查支持 FDA Inspections Support IMPORTED/DOMESTIC MEDICAL 专家会议支持 FDA Panel Meetings DEVICE REGISTRATION FDA 要求的年度报告 FDA Annual Reporting 撰写设计文档 Compile EU Design Dossier 医疗器械类别：一类、二类、三类 法规差距分析 Regulatory Gap Assessment Medical Device Category: Class I, II, III MDR 临床评价报告 MDR CER 临床评价 CER Clinical Evaluation CER 技术文件差距分析 Technical File Gap Assessment 分类界定 Classification and Definition 质量管理体系支持 QMS Support 检测服务 Testing Services 特殊类别 SPECIAL CATEGORY 真实世界数据用于医疗器械临床评价 Real World Data for Clinical Evaluation of Medical Devices 创新医疗器械申报 Application for Innovative Medical Devices 优先审批 Priority Approval 注册人制度申报 Registration System Declaration 5

为什么选择金石医疗？ WHY CHOOSE KINGROCK? 实验室软硬件 公司实验室按照国际标准建立，符合 GLP 质量体系要求；实验室配备有国际一流的 DSA LAB SOFTWARE \& HARDWARE 手术室及手术设备，可满足各类植入介入类手术的临床前实验需求。 Our lab is established according to the international standards and GLP quality system requirements, and also equipped with world-leading DSA operating room and surgical equipment, which can meet the pre clinical experimental needs of various kinds of implantation and interventional surgery 权威专家 金石团队成员均来自国际公告机构、国内外知名 CRO 公司以及医疗器械研发生产企业， PROFESSIONAL TEAM 紧跟国内外医疗器械政策法规的监管动向，为客户提供从产品开发初期的策略建议、方案 设计，到项目的运营管理、总结分析，直至成功获批投放市场，甚至是上市监管等一系列专 业服务。在保证实验项目持续高效运营的同时，准确识别潜在风险，将运营以及研究的不 可控因素降至最低。 Team members of KINGROCK originate from international notified body, well-known CRO companies and medical device companies and the abundant experience in each stage of clinical trials and observational studies will help to provide customers with comprehensive professional services from strategy development, protocol design, project operation, data management and analysis to registration. This will optimize project management operations, raising efficiency and minimizing risks during trials operation. 全球资源 金石拥有遍布全球的医疗专家资源，并与主流研究中心及研究者长期保持密切的合作关 GLOBAL RESOURCES 系，同时与 NMPA、CMDE 等药监部门有着良好的联系，帮助企业减少沟通成本，缩短上市 周期。 We maintain excellent cooperative relationships with key investigational sites and investigators and we have also maintained good relations with NMPA, CMDE and other regulatory supervision departments. 专业合规 作为值得信赖的专业第三方服务机构，我们为企业提供可靠且准确的测试及研究服务，我 QUALITY \& COMPLIANCE 们在满足法规要求并将项目推向市场方面具有极其丰富的经验。 As a reliable professional third-party service provider, we provide reliable and accurate testing and research services, and we are excellence in meeting regulato- ry compliance and bringing projects to market. 6

我们提供跨职能及跨部门的合作， 以帮助您的产品快速和有效的商业化。 我们的主要目标是加速您的产品推向市场， 帮助您实现更大的投资回报， 最重要的是， 为人们带来更安全的医疗器械产品。 扫码关注金石医疗 广东金石医疗科技服务有限公司 获取最新行业资讯 总机：+86-20-31709160 邮箱：info@krockmed.com 网址：www.krockmed.com 地址：广东省广州市黄埔区开源大道 11 号 C5 栋 201 室