Hệ thống Quản lý Chất lượng Thiết bị Y tế - ISO 13485:2016

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.