Course Objectives
At the end of the program participants should:
-
Understand the philosophy and principles of QMS of Medical Device.
​
-
Aware of fundamental concepts and QMS requirements.
​
-
Understand key factors for developing QMS for the organization.
​
-
Understands the importance of developing QMS in the organization.
Course Outline
UNIT 1: Overview of QMS for Medical Devices
​
-
History and background of changes
-
Important points in ISO 13485:2016
UNIT 2: Key Factor of QMS for Medical Devices
​
-
Introduction of ISO 13485:2016
-
Walkthrough of the clauses of ISO 13485:2016
​​
Target Audience
Quality Personnel, QA/QC Lab technician, and QA/QC Executive
Go further.
Request a quote for our accredited services, we will get back to you in the next couple of business days.
Duration
-
2 full-day courses
-
Physical Training (On-site).
Advancement trough training
We provide:
Diverse learning methods:​
classroom-based, virtual, and blended courses
Industry-specific solutions:
tailored training for medical device manufacturers and sterilizers
Customized learning:
bespoke training solutions based on industry needs
Standard-based training:
comprehensive ISO and other standard-specific courses
Specialized subject training:
covering microbiology techniques and validation of test methods
Industry-experienced trainers:
expert trainers with years of experience in the industry
ISO 13485 Training
Medical Devices - Quality Management System
​
-
Philosophy and principles of QMS of Medical Device.
​
-
Fundamental concepts and QMS requirements.
​
-
Key factors for developing QMS for the organization.
​
-
Importance of developing QMS in the organization.