ISO 13485:2016 – International Medical Device QMS Standard

NSF International, Health Sciences
Course summary
Professional Training
2 hours
400 USD excl. VAT
Online courses
Course Dates
Online courses
400 USD
Start anytime

Course description

ISO 13485:2016 – International Medical Device QMS Standard

This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard which serves as a basis for many medical device quality management system (QMS) regulations around the globe. This course covers the goals of the standard and in-depth instruction regarding Clause 4-QMS; Clause 5-Management Responsibility; Clause 6-Resource Management; Clause 7-Product Realization; and Clause 8-Measurement Analysis and Improvement.

Outcome / Qualification etc.


By completing/passing this course, you will attain the certificate Medical Device Certificate

Training Course Content

By the end of this course you should be able to:

  • Define the primary purpose of ISO 13485:2016
  • Identify the general and documentation requirements of a QMS as outlined in Clause 4
  • Recognize the responsibilities of management within a QMS as outlined in Clause 5
  • Identify the resources needed to implement and maintain an effective QMS; and meet regulatory and customer requirements as outlined in Clause 6
  • Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
  • Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider


Course price: $399.99

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

Customer Outreach Award


We believe that it should be easy for you to find and compare training courses. 

Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.

About provider

NSF - Professional Health and Life Sciences Courses

NSF provides training and education services for leading organisations in the health care industries. Our health sciences courses have one objective – to bring about change that drives improvements in your workplace. Known globally for high-quality content, we are passionate...

Read more and show all courses with this provider

Request info

Fill out your details to find out more about ISO 13485:2016 – International Medical Device QMS Standard.

  Contact the provider

  Get more information

  Register your interest

Country *

Contact info

NSF International, Health Sciences

The Georgian House, 22/24 West End
YO62 6AF York

Request information

Find out more about this ISO 13485:2016 – International Medical Device QMS Standard course - simply fill out your details:

Find a course for you!

  Read the course
 summary on this page

 Fill in your details and Request information

 Receive all the info you need

Case Study
The Journal by NSF Health Sciences
NSF International, Health Sciences

NSF Health Sciences have produced a number of journal articles that are released a number of times throughout the year. Here you can download some of the latest articles.

Read more
Find more courses here