Medical Devices Quality Management System – ISO 13485:2016

Medical Devices Quality Management System – ISO 13485:2016, available at $44.99, has an average rating of 4.28, with 9 lectures, based on 794 reviews, and has 2026 subscribers.

You will learn about How ISO 13485 requirements apply to medical device companies Requirements of the ISO 13485:2016 standard The importance of implementing a Quality Management System per ISO 13485:2016 This course is ideal for individuals who are Medical device companies looking to set up their QMS and get ISO 13485:2016 certified or Professionals tasked with overseeing a management system meeting ISO 13485 standards or Quality managers or Risk managers or Medical device practitioners interested in the ISO 13485 framework It is particularly useful for Medical device companies looking to set up their QMS and get ISO 13485:2016 certified or Professionals tasked with overseeing a management system meeting ISO 13485 standards or Quality managers or Risk managers or Medical device practitioners interested in the ISO 13485 framework.

Enroll now: Medical Devices Quality Management System – ISO 13485:2016

Summary

Title: Medical Devices Quality Management System – ISO 13485:2016

Price: $44.99

Average Rating: 4.28

Number of Lectures: 9

Number of Published Lectures: 9

Number of Curriculum Items: 9

Number of Published Curriculum Objects: 9

Original Price: $124.99

Quality Status: approved

Status: Live

What You Will Learn

How ISO 13485 requirements apply to medical device companies
Requirements of the ISO 13485:2016 standard
The importance of implementing a Quality Management System per ISO 13485:2016

Who Should Attend

Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
Professionals tasked with overseeing a management system meeting ISO 13485 standards
Quality managers
Risk managers
Medical device practitioners interested in the ISO 13485 framework

Target Audiences

Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
Professionals tasked with overseeing a management system meeting ISO 13485 standards
Quality managers
Risk managers
Medical device practitioners interested in the ISO 13485 framework

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.

Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide.

With this need for implementation, comes a need for understanding of the requirements.

The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device.

In this course, we will walk through the ISO 13485:2016 standard to:

Clarify on the concepts
Show how it relates to business processes
Elaborate on the practical application

You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations.

Furthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs.

Understand and implement a best-practice Quality Management System as per requirements for the medical industry.

Get the information you need to design, coordinate and improve your company’s QMS as per ISO 13485:2016.

Course Curriculum

Chapter 1: Introduction – Getting started on the ISO 13485:2016

Lecture 1: Introduction to ISO 13485:2016

Chapter 2: Clauses-by-clause guidance for ISO 13485:2016

Lecture 1: Clauses 1 to 3 + Clause 4: Quality Management System

Lecture 2: Clause 5: Management Responsibility + Clause 6: Resource Management

Lecture 3: Clause 7: Product Realization

Lecture 4: Clause 8: Measurement, Analysis and Improvement

Chapter 3: Preparation of documentation

Lecture 1: Preparation of documentation

Chapter 4: Implementation

Lecture 1: Implementation

Chapter 5: Verification of your implementation

Lecture 1: Verification of your implementation

Lecture 2: Bonus Lecture

Instructors

Stendard Academy
The Stendard Academy

Rating Distribution

1 stars: 15 votes
2 stars: 29 votes
3 stars: 142 votes
4 stars: 334 votes
5 stars: 274 votes

Frequently Asked Questions

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