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所在平台: Udemy |
课程主页: https://www.udemy.com/course/fda-compliant-medical-device-development-and-manufacturing/
课程评论：没有评论
**Coursera 课程摘要：医疗器械开发与制造（从概念到上市）** 本课程由拥有30多年医疗器械行业经验的CEO倾力打造，旨在为有志于进入这一领域的创业者、企业管理人员、学生及相关从业者提供一个从概念构思到产品上市的全方位概览。课程将深入浅出地讲解如何符合FDA及国际法规要求进行医疗器械的开发与制造。 **课程核心内容：** * **监管合规性：** 详细介绍FDA及国际法规要求，帮助学员理解并遵循复杂的监管流程。 * **开发与制造流程：** 涵盖从产品概念、设计、设计评审、流程开发、验证与确认，到最终的合规生产、质量控制、供应链管理以及厂房设施要求。 * **组织结构与质量体系：** 阐述医疗器械公司所需的组织结构以及包含所有监管要求的质量手册。 * **文档控制：** 强调设计和制造过程中文档控制的必要性及要求。 * **医疗仪器与一次性无菌器械：** 涵盖特定类型医疗器械的开发与制造考量。 **课程目标受益群体：** * **创业者：** 了解开发制造医疗器械所需的资源和流程，以便准确评估融资需求。 * **医学生：** 对拥有医疗器械创意并希望成为创业者的学生，提供前期指导。 * **工程及各学科学生：** 为有志于在医疗器械行业发展事业的学生提供职业规划方向。 * **医疗器械行业管理人员及高管：** 提升管理能力，优化部门运作，并为招聘合格人才提供参考。 * **医生、护士及医院工作人员：** 了解器械开发和制造的概述，以更好地理解和使用医疗器械。 本课程为“概览性”教学，强调关键流程和必要的监管指南，旨在帮助学员做出明智的职业决策，并为他们在医疗器械行业的成功奠定基础。
As a Founder and CEO of Good Cards Medical International, I would like to welcome you to this course & learn about 'OVERVIEW of how to develop and manufacture medical devices in compliance with FDA & International regulations'. I do have 30+ years of hands on and managment experience with medical device industry in USA with fortune 500 and startup companies with device development involvement and A - Z manufacturing operations management. My passion and vision is to share this knowledge and experience for the success of world wide medical device current entrepreneurs, established device company executives plus management and staff, future entrepreneurs from medical and engineering students from all desciplines and other educated beneficiaries interested in a very satisfying career in medical device industry. Medical device development and manufacturing process is extremely detailed with several regulatory requirements, but once understood it becomes easy to follow the regulations. This industry does require proper qualified support organization. In addition to the current entrepreneurs, there are multiple opportunities for educated personnel to be part of this wonderful world wide medical device industry. All educated personnel have a place in this industry. All you need is a strong desire. This course definitely gives an OVERVIEW ONLY from A - Z of what is involved. Please remember this is an OVERVIEW with several pointers towards required regulatory guidelines. This course will & should help interested beneficiaries to make proper decisions about their career and career plans. This course covers process information about how to develop medical devices from concept all the way to commercial shipment, including regulatory guidelines and requirements. It does include Medical Instrumentation and sterilized disposable devices. Given below is required key structure & development processes.Company's required organizational structure for device developmentCompany Quality Manual which includes all regulatory requirementsDevice design & design reviewsDevice design & manufacturing process development and verifications / validationsFinal regulatory compliant manfucaturing production Manufacturing Quality ControlsDevice design and manfucaturing documentation controls & requirements Supply chain qualifications and monitoring Regulated facilities requirements This course will benefitEntrepreneurs who should know what is required to develop and manufacture a medical device so they can confidentially know details to determine the level of funding required for a successful company.Medical students who have device ideas and aspire to be medical device Entrepreneurs & should know upfront what is involvedAll desciplines of engineering students with a strong desire for a career in medical device industryCollege students with all desciplines with a strong desire for a career in medical device industryDevice industry management personnel & executives to possess proper information so they can manage departments properly for company's success and also help them hire qualified personnel Doctors, Nurses and hospital staff to understand device development and manufacturing overview information to develop an appreciation for the devices
