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


 

 

Course programme

Day 1

  • Introduction
  • The regulatory framework
  • Standards
  • 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
  • Traceability
  • Design changes
  • Internal audits
  • CAPA
  • Complaints
  • Repetition

 

 

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


Yes, it is the latest version. For those who are still on the older version, we mention the differences throughout the course by highlighting what is new.

Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.

For the course price, you will get the course, course material, templates , coffee and snacks throughout the day and snacks. For courses held in Hörsholm, also breakfast is included.

There is no certification or accreditation for risk management, however the instructor has documented training in the field since many years and participated in authoring the ISO 13485:2016 standard in JWG1

The maximum number is 15. Any more than 15 people inhibits the interactive elements

Sure, I will be happy to send a proposal for a company internal version of this course to you. Use the contact form to request a proposal.

There are no pre-requisites for this course.

Yes, but only if you are present 75% or more of the course duration. You also have to be active on the course to be eligible for the certificate.

Please request the course programme by filling out the form below to get the programme including pricing and early bird discounts when applicable.

Please request the course programme by submitting the form below. Dates and venues are found for each course in the programme. The programme also contains more detailed information on the course than this page.

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.

Get more info about the course

Enter your details below to request more information about our professional courses in medical device product development. Or simply call us on +46 708 186 800.