|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/medical-device-design-development-control-iso-13485/
课程评论：没有评论
课程名称：医疗器械设计与开发控制，ISO 13485 课程概述：本课程分为10个部分，旨在阐明医疗器械设计与开发控制的标准要求。课程将介绍医疗器械设计师为满足设计合规性、获得监管机构批准以便在市场上销售设备所需进行的步骤。内容遵循ISO 13485标准的第7.3节，并引用MDR 2017/745和CFR 820.30，讲解在美国、欧盟及全球范围内获得批准所需的步骤。 在课程开始时，我将解释著名的瀑布设计图，并在总结讲座中验证这一解释。课程还提供一些资源，如测验、标准、法规、指导方针、模板和案例研究。 1. **一般/设计与开发规划**：探讨标准第7.3.1和7.3.2部分，强调设计与开发过程的规划及文档记录，使用支架的案例贯穿整个设计过程，以便更好地理解。 2. **用户需求/预期目的**：明确医疗器械的“预期目的”及其治疗的疾病，分析用户需求的来源，强调利益相关者的不同意见。 3. **设计与开发输入**：了解如何将用户需求转化为设计方案，探讨可追溯性的重要性，并通过输入-输出验证验证矩阵（IOVV）进行演示，强调风险分析在设计中的应用。 4. **设计与开发输出**：解释设计输出的定义，即产品的规格，要求设计输出需满足设计输入。 5. **设计与开发评审**：指出在设计与开发的每个阶段应进行设计过程评审，并记录、授权签字才能进入下一个阶段。 6. **设计与开发验证**：探讨ISO 13485标准关于设计和开发验证的内容，确保设备的规格正确，并通过示例说明验证测试。 7. **设计与开发确认**：简明解释确认的概念，确保设备按预期功能运行。 8. **设计与开发转移**：讲解设计转移的含义及产品如何在市场上生产和销售，并通过案例研究强调其重要性。 9. **设计与开发变更**：控制设计变更的重要性及其管理方式，通过案例研究讨论。 10. **设计与开发技术文件**：强调整个设计控制过程需被文档记录和存档，研究与美国法规相关的设计历史文件、设备主记录、设备历史记录，以及与欧盟法规相关的技术文档。 本课程为医疗器械设计与开发提供了全面的指导，确保设计过程的合规性和有效性。
The course is broken into 10 sections. The objective of the course is to explain what is the standard requirement for medical device design and development control. What does the medical device designer needs to do in order to be be compliant to design and therefore get approval from a regulatory authority to be able to sell the device on the market place.It follows sections 7.3 of the ISO 13485 standard for design and development control of a medical device. It also references MDR 2017/745 and CFR 820.30. It will explain what needs to be done gain approval in the US, EU and globally.In the introduction I will explain the famous Waterfall design diagram and I validate this explanation in the recap lecture.I have attached resources such as quizzes, standards, regulations, guide lines, templates and case studies. In Section 1: General/Design & Development planning.In this section we will examine section 7.3.1 & 7.3.2 of the standard which explains that design and development needs to be planned and this planning process must be documented.To give context to the design and development process and to help to understand it better we will look at an example of a medical device which is a stent. We will use this example throughout the design process to illustrate better understanding.Section 2: User need/Intended Purpose.In Section two we will understand what is meant by "Intended Purpose" what do we want the medical device to do. What disease is it going to treat.Once we have defined the intended purpose, we need to understand what the user needs are and where do they come from. This can come from a lot of sources, and we will explain that. One main point here is stakeholders have different opinions on what they need the device to do.Section 3 Design & Development Inputs.We need to understand how the User needs which is what the user wants. We need to learn how to translate this into a how.With this we will look at how important traceability is. Each step in the process is linked and I will explain this via the Input Output Verification Validation matrix. IOVV. We will understand how risk analysis must be used to identify any risks which will lead to amendments in the design.Section 4: Design & Development Outputs.In this section design outputs are explained. In my simple definition the design outputs are the specification of the product.I will explain the design outputs must satisfy the design inputs.Section 5: Design & Development Review.We will understand that at each stage of the design and development process there should be a review of the design process. It needs to be documented and a person in authority within the organization must sign off on the review to allow it to go to the next stage.Section 6: Design & Development VerificationWe will understand what the ISO 13485 standards says about Design and Development Verification. Which is in section 7.3.6 of the standard.We will understand what verification is. You are ensuring that the specification of the device is correct.I will explain what verification tests are by way of illustration with examples.Section 7 Design and Development ValidationI will explain what the standard says about validation.I will explain what it is in simple terms. Is the device functioning as we intend it.Section 8 Design and Development Transfer:What is meant by design transfer. The product must eventually be made and sold in the marketplace. I will explain how this is going to be done.I will explain in a case study how important design transfer is.Section 9 Design and Development changesDesign Changes need to be controlled. I will explain how this needs to be done.I will discuss how important it is to control these changes via a case study.Section 10 Design and development Technical files.We need to understand that the whole design control process needs to be documented, recorded and stored.We will look at Design History File, Device Master Record, Device History Record which is associated with the US regulation and the Technical documentation which is associated with the European Union Regulation.
