Quality Management System for Medical Devices-ISO 13485

Quality Management System for Medical Devices-ISO 13485, available at $44.99, with 16 lectures.

You will learn about Identify and explain the key requirements of the standard, including its structure, core principles (risk-based approach, process approach). Develop the ability to apply ISO 13485 concepts to practical situations within medical device companies, using real-world examples and scenarios. Gain the knowledge and tools to design, implement, and maintain an effective QMS that aligns with ISO 13485, including developing quality documentation. Understand how ISO 13485 contributes to the development and delivery of safe and effective medical devices, recognizing its role in minimizing risks. This course is ideal for individuals who are Medical Device Professional wanting to learn about ISO 13485 Standard for Quality Managament System. It is particularly useful for Medical Device Professional wanting to learn about ISO 13485 Standard for Quality Managament System.

Enroll now: Quality Management System for Medical Devices-ISO 13485

Summary

Title: Quality Management System for Medical Devices-ISO 13485

Price: $44.99

Number of Lectures: 16

Number of Published Lectures: 16

Number of Curriculum Items: 16

Number of Published Curriculum Objects: 16

Original Price: $124.99

Quality Status: approved

Status: Live

What You Will Learn

Identify and explain the key requirements of the standard, including its structure, core principles (risk-based approach, process approach).
Develop the ability to apply ISO 13485 concepts to practical situations within medical device companies, using real-world examples and scenarios.
Gain the knowledge and tools to design, implement, and maintain an effective QMS that aligns with ISO 13485, including developing quality documentation.
Understand how ISO 13485 contributes to the development and delivery of safe and effective medical devices, recognizing its role in minimizing risks.

Who Should Attend

Medical Device Professional wanting to learn about ISO 13485 Standard for Quality Managament System.

Target Audiences

Medical Device Professional wanting to learn about ISO 13485 Standard for Quality Managament System.

This comprehensive video course provides a deep dive into the requirements of ISO 13485:2016, the international standard for quality management systems in the medical device industry. Through engaging lectures, real-world examples, and clear explanations, you’ll gain a practical understanding of how to build, implement, and maintain a robust QMS that meets the rigorous demands of this critical field.

Who Should Take This Course:

Quality professionals working in medical device companies
Regulatory affairs personnel
Engineers and designers involved in medical device development
Management and leadership teams responsible for quality
Anyone seeking to understand or implement ISO 13485

What You Will Learn:

The structure, core principles, and key requirements of ISO 13485:2016
How to apply a risk-based approach and process approach to your QMS
Essential QMS documentation, including the Quality Manual and Medical Device Files
Management’s role in driving a culture of quality and ensuring compliance
Effective resource management, including human resources, infrastructure, and work environment
The stages of product realization, from design and development to purchasing, production, and post-market surveillance
Key tools for measurement, analysis, and improvement, including corrective and preventive action

By the end of this course, you’ll be able to:

Confidently navigate the requirements of ISO 13485:2016
Apply its principles to practical scenarios in your organization
Contribute to building and maintaining an effective medical device QMS
Enhance your understanding of how quality management impacts medical device safety and effectiveness

Start your journey towards medical device excellence today! Enroll in our Mastering ISO 13485:2016 course.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Chapter 2: Normative References

Lecture 1: Normative references

Chapter 3: Terms and Definitions

Lecture 1: Terms and Definitions of ISO13485

Chapter 4: Quality Management System

Lecture 1: General Requirements of QMS

Lecture 2: Documentation Requirements of QMS

Chapter 5: Management Responsibility

Lecture 1: Management Commitment, Customer Focus and Quality Policy

Lecture 2: Planning, Responsibility and Management Review

Chapter 6: Resource Management

Lecture 1: Provision of Resource & Human Resources

Lecture 2: Infrastructures and Work Environment

Chapter 7: Product Realization

Lecture 1: Overview of Product Realization & Customer Related Process

Lecture 2: Design Planning, Inputs and Outputs

Lecture 3: Design Verification, Validation and Transfer

Lecture 4: Purchasing, Identification and Control

Lecture 5: Design and Development Files

Chapter 8: Measurement, Analysis and Improvement

Lecture 1: Monitoring, Non-conformances and CAPA

Lecture 2: Analysis of Data and Improvement

Instructors

Anil Sharma Kandel
Industrial and Manufacturing Engineer

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Frequently Asked Questions

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