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ISO 13485:2016 Interpretation & Implementation Training
ISO 13485:2016 Interpretation & Implementation Training
Category: Medical Devices QMS Related Training
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 daysSuitable 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.Contact us for the synopsis.
ISO 13485:2016 Interpretation & Implementation Training
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