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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso13485-medical-devices-qms/
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课程名称：医疗器械质量管理体系 - ISO 13485:2016 课程概述：ISO 13485:2016标准规定了医疗器械开发和质量管理体系（QMS）的要求，适用于医疗器械相关公司。拥有一个适当的质量管理体系对医疗器械公司至关重要。全球的监管要求强调这一点，并使公司遵循这些标准成为强制性。随着实施需求的增加，对标准的理解变得尤为重要。本课程旨在阐明ISO 13485:2016标准在医疗器械公司及其开发中的应用。 本课程将深入分析ISO 13485:2016标准，具体包括： - 清晰解释相关概念 - 展示标准如何与业务流程相关联 - 详细讲解实际应用 您将学习到的内容包括：标准要求的具体内容和对您运营有利的最佳实践指南。此外，您还可以开始准备相关文件（质量手册、标准操作程序等），以便立即实施这些操作。课程将帮助您理解并按照医疗行业的要求实施最佳实践的质量管理体系，获取必要的信息，以设计、协调和改善公司符合ISO 13485:2016的质量管理体系。
The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies. Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide. With this need for implementation, comes a need for understanding of the requirements.The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device. In this course, we will walk through the ISO 13485:2016 standard to: Clarify on the conceptsShow how it relates to business processesElaborate on the practical applicationYou can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations. Furthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs. Understand and implement a best-practice Quality Management System as per requirements for the medical industry. Get the information you need to design, coordinate and improve your company's QMS as per ISO 13485:2016.
