Iso 13485 Standard For Medical Devices- From A To Z [2023]
Published 5/2023
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 4.57 GB | Duration: 3h 37m
Become an expert in Quality Management system and learn ISO 13485 directly from the standard guidelines.
What you'll learn
Comprehensive course on the ISO 13485 standard for medical device quality management systems
Provides a thorough understanding of the requirements and best practices for implementing and maintaining an ISO 13485 compliant quality management system
3-hour course covers each section and subsection of the standard, from beginner to advanced levels
Topics covered include: 1) Scope and application of the standard 2) Quality management system requirements 3) Management responsibility 4) Resource management..
By the end of the course, participants will have the knowledge and skills necessary to effectively implement and maintain an ISO 13485 compliant QMS system
Requirements
No Prior Experience Required. Course goes from Beginner to Advance levels
Description
This comprehensive course on the ISO 13485 standard for medical device quality management systems is designed to provide participants with a thorough understanding of the requirements and best practices for implementing and maintaining an ISO 13485 compliant quality management system. Over the course of 3 hours, participants will be guided through each section and subsection of the standard, from beginner to advanced levels.The ISO 13485 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This course will cover the scope and application of the standard, as well as the specific requirements for a quality management system that meets the standard.Participants will learn about management responsibility, including the importance of top management commitment to the quality management system and the need for effective communication within the organization. The course will also cover resource management, including the provision of resources necessary to implement and maintain the quality management system, as well as the training and competence of personnel.The product realization section of the course will cover topics such as planning of product realization, customer-related processes, design and development, purchasing, production and service provision, and control of monitoring and measuring equipment. Participants will also learn about measurement, analysis and improvement, including monitoring and measurement of processes and products, control of nonconforming product, analysis of data, and continual improvement.By the end of the course, participants will have a thorough understanding of the requirements and best practices for implementing and maintaining an ISO 13485 compliant quality management system. They will have the knowledge and skills necessary to effectively implement and maintain a quality management system that meets the requirements of the ISO 13485 standard.
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 Overview on ISO 13485
Lecture 3 ISO 13485 VS ISO 9001 - Similarities and Differences
Lecture 4 Overview of ISO 13485 Standard
Section 2: Normative Reference & Definitions from ISO 13485
Lecture 5 Scope, Normative Reference and Definitions
Section 3: Quality Management System Requirements
Lecture 6 General and Documentation Requirement of QMS
Section 4: Management Responsibility
Lecture 7 Management Commitment, Customer Focus, Quality Policy
Lecture 8 Planning
Lecture 9 Responsibility, authority and communication
Lecture 10 Management Review
Section 5: Resource Management
Lecture 11 Provision of Resources & Human Resource
Lecture 12 Human Resources
Section 6: Product Realization
Lecture 13 Planning of Product Realization
Lecture 14 Customer Related Processes
Lecture 15 Design Inputs
Lecture 16 Design Output
Lecture 17 Design Review
Lecture 18 Design Verification and Validation
Lecture 19 Control of Design and Developmental Changes
Lecture 20 Purchasing
Lecture 21 Production and Service Provision
Lecture 22 Control of Monitoring and Measuring Device
Section 7: Measurement Analysis and Improvement
Lecture 23 Customer Feedback and Non Conformances
Lecture 24 Analysis of Data
Lecture 25 Corrective Action and Preventative Action
Section 8: Advantage of ISO 13485 and Conclusion
Lecture 26 ISO 13485 Advantage
Medical Device Industry Professional Looking to Learn about ISO 13485 standard or seasoned professionals looking to refresh their skills.
HOMEPAGE
Code:
https://www.udemy.com/course/isostandard/DOWNLOAD
Code:
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