Iso 13485 Standard For Medical Devices- From A To Z [2023]

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.