ISO 13485 Standard For Medical Devices- From A to Z [2024]

ISO 13485 Standard For Medical Devices- From A to Z [2024], available at $59.99, has an average rating of 4.06, with 26 lectures, based on 112 reviews, and has 319 subscribers.

You will learn about 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 This course is ideal for individuals who are Medical Device Industry Professional Looking to Learn about ISO 13485 standard or seasoned professionals looking to refresh their skills. It is particularly useful for Medical Device Industry Professional Looking to Learn about ISO 13485 standard or seasoned professionals looking to refresh their skills.

Enroll now: ISO 13485 Standard For Medical Devices- From A to Z [2024]

Summary

Title: ISO 13485 Standard For Medical Devices- From A to Z [2024]

Price: $59.99

Average Rating: 4.06

Number of Lectures: 26

Number of Published Lectures: 26

Number of Curriculum Items: 26

Number of Published Curriculum Objects: 26

Original Price: $94.99

Quality Status: approved

Status: Live

What You Will 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

Who Should Attend

Medical Device Industry Professional Looking to Learn about ISO 13485 standard or seasoned professionals looking to refresh their skills.

Target Audiences

Medical Device Industry Professional Looking to Learn about ISO 13485 standard or seasoned professionals looking to refresh their skills.

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.

Course Curriculum

Chapter 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

Chapter 2: Normative Reference & Definitions from ISO 13485

Lecture 1: Scope, Normative Reference and Definitions

Chapter 3: Quality Management System Requirements

Lecture 1: General and Documentation Requirement of QMS

Chapter 4: Management Responsibility

Lecture 1: Management Commitment, Customer Focus, Quality Policy

Lecture 2: Planning

Lecture 3: Responsibility, authority and communication

Lecture 4: Management Review

Chapter 5: Resource Management

Lecture 1: Provision of Resources & Human Resource

Lecture 2: Human Resources

Chapter 6: Product Realization

Lecture 1: Planning of Product Realization

Lecture 2: Customer Related Processes

Lecture 3: Design Inputs

Lecture 4: Design Output

Lecture 5: Design Review

Lecture 6: Design Verification and Validation

Lecture 7: Control of Design and Developmental Changes

Lecture 8: Purchasing

Lecture 9: Production and Service Provision

Lecture 10: Control of Monitoring and Measuring Device

Chapter 7: Measurement Analysis and Improvement

Lecture 1: Customer Feedback and Non Conformances

Lecture 2: Analysis of Data

Lecture 3: Corrective Action and Preventative Action

Chapter 8: Advantage of ISO 13485 and Conclusion

Lecture 1: ISO 13485 Advantage

Instructors

Anil Sharma Kandel
Industrial and Manufacturing Engineer

Rating Distribution

1 stars: 5 votes
2 stars: 6 votes
3 stars: 24 votes
4 stars: 38 votes
5 stars: 39 votes

Frequently Asked Questions

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