ISO 13485:2016 – Implementation Training
Course Outline
The ISO 13485:2016 standards specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that meet customer and regulatory requirements. Major regulatory bodies worldwide require certification to ISO 13485 to allow organizations to market their products and services.
Objective
To provide all the essential tools required to implement a medical devices management system based on the ISO 13485:2016 standards, adding value to the organization.
Prerequisite
It is recommended that each participant brings a copy of the standard. Only electronic copies will be made available during the course.
Topics Include:
- Introduction.
- ISO 3485:2016 requirements– detailed studies
Who should attend:
- Organizations that want to implement a system based on ISO 13485
- Managers. supervisors involved in the implementation process
Certification
- Upon completion of the course each attendee will receive an attendance certificate.
- Our courses are recognized by certification/accreditation bodies.
- CEUs: 1.6
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- In-house training information and quote
- Special dietary requirements
- Any question
Cost: CONTACT US FOR A QUOTE; includes course materials.