ISO 13485:2016 Interpretation & Implementation Training

Category: Medical Devices QMS Related Training

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Course Objective

Understanding what is medical devices
Basic knowledge on the ISO 13485
An interpretation of the ISO 13485 requirements

Course Highlight:

A lot of practical activities are available to link the ISO 13485:2016 requirement to the actual scenario.

This course covering the topics indicated below:

Introduction of the ISO 13485
The ISO 13485 Evolution
The ISO 13485 Foundation
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis and Improvement
Pathway for ISO 13485 New Certification

Duration:

2 days

Suitable for:

This course is designed for the employees from all the function/levels whom would like to gain understanding on the ISO 13485 requirements, including those from the organizations that are currently certified to ISO 13485:2016 or yet to certified. This course is particularly essential for those direct involve in the QMS management and internal auditors.