Quality Management System For Medical Devices-Iso 13485

Learn all the sections and subsections of the ISO13485 QMS standard for the expert!

What you'll 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.

Requirements

No experience or prior curriculum required

Description

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 companiesRegulatory affairs personnelEngineers and designers involved in medical device developmentManagement and leadership teams responsible for qualityAnyone seeking to understand or implement ISO 13485What You Will Learn:The structure, core principles, and key requirements of ISO 13485:2016How to apply a risk-based approach and process approach to your QMSEssential QMS documentation, including the Quality Manual and Medical Device FilesManagement's role in driving a culture of quality and ensuring complianceEffective resource management, including human resources, infrastructure, and work environmentThe stages of product realization, from design and development to purchasing, production, and post-market surveillanceKey tools for measurement, analysis, and improvement, including corrective and preventive actionBy the end of this course, you'll be able to:Confidently navigate the requirements of ISO 13485:2016Apply its principles to practical scenarios in your organizationContribute to building and maintaining an effective medical device QMSEnhance your understanding of how quality management impacts medical device safety and effectivenessStart your journey towards medical device excellence today! Enroll in our Mastering ISO 13485:2016 course.

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: Normative References

Lecture 2 Normative references

Section 3: Terms and Definitions

Lecture 3 Terms and Definitions of ISO13485

Section 4: Quality Management System

Lecture 4 General Requirements of QMS

Lecture 5 Documentation Requirements of QMS

Section 5: Management Responsibility

Lecture 6 Management Commitment, Customer Focus and Quality Policy

Lecture 7 Planning, Responsibility and Management Review

Section 6: Resource Management

Lecture 8 Provision of Resource & Human Resources

Lecture 9 Infrastructures and Work Environment

Section 7: Product Realization

Lecture 10 Overview of Product Realization & Customer Related Process

Lecture 11 Design Planning, Inputs and Outputs

Lecture 12 Design Verification, Validation and Transfer

Lecture 13 Purchasing, Identification and Control

Lecture 14 Design and Development Files

Section 8: Measurement, Analysis and Improvement

Lecture 15 Monitoring, Non-conformances and CAPA

Lecture 16 Analysis of Data and Improvement

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