Medical Devices Quality Management System - ISO 13485:2016
- 4.1
-
![]()
![]()
![]()
![]()
Brief Introduction
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS.Description
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.
Requirements
- Requirements
- No specific prior knowledge is required
- Familiarity with quality management systems is helpful
- A general understanding of medical device life-cycle is useful
- Owning the ISO 13485:2016 standard is optional but recommended
Stendard Academy
4.1 Raiting
Medical Devices Quality Management System - ISO 13485:2016
- 4.1
-
![]()
![]()
![]()
![]()
![]()
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS. Having a proper QMS in place is essential for medical device-related companies....
Internal audit on Medical Device QMS - ISO 13485:2016
- 4.3
-
![]()
![]()
![]()
![]()
![]()
Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS It is an essential standard for medical device development companies....
