Quality management for medical devices and ISO 13485
This 1 day course includes the latest information on the ISO 13485 including the 2016 version. You will learn how to effectively work within the relevant requirements.
This course is aimed at professionals who work in a medical devise organisation where ISO 13485 requirements apply. The course is set up to provide tangible and useable knowledge about the requirements of the ISO 13485 and includes the latest in the ISO 13485 2016 version and how to meet the requirements.
Benefits for you
Be able to work according to ISO 13485 requirements
Are you new to a company, or trying to figure out how to work according to ISO 13485 requirements? The course will give you the understanding you need to work according to your company’s procedures and ISO 13485 requirements.
Understand what your colleagues and auditors are saying
There is a lof of industry specific language and terminology. During the course you will be introduced to a lot of words and concepts that will help you understand your colleagues and auditors and you won’t have to ask twice.
A practical approach
If you want to just learn about the requirements of the standard, I recommend reading the standard. If you want to learn more about how to implement the requirements, this course provides as much answers as possible during one day to that question
- The regulatory framework
- Product approval process
- Introduction to ISO 13485
- Introduction to risk
- The Quality Management System
- Audits and compliance
- Document and record control
- Medical device files
- Management responsibility
- Resource management
- Product realization – Design
- Product realization – Purchasing
- Product realization – Manufacturing
- Product realization – Process Validation
- Design changes
- Internal audits
Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
Frequently asked Questions
Register for a course
If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.