Medical Device Quality Management Systems (QMS)

Key requirements in ISO 13485, MDR *, and QSReg **

*MDR – EU Medical Device Regulation **QSReg – US Medical Device Regulation 21 CFR 820


During this three day course you will get a good insight and understanding of the key requirements that shall be fulfilled to establish and maintain a quality management system in compliance with EU and US Medical Device regulations.

Course description:

The course provides practical guidance on how to implement the requirements in your quality management system and how to deal with critical elements of the quality management system such as; design control (product development), manufacturing, validation, management responsibilities, handling of resources, internal audits, change control, post market surveillance and CAPA management. During the course you will also get a thorough understanding of the major changes in the newly updated ISO 13485:2016, as compared to the 2003/2012 version and its relation to the new Medical Device regulations (MDR/IVDR).

Course outline

  • Purpose of a Quality System
  • Process approach
  • Management responsibility and human resources
  • CAPA system
  • Document controls; interrelations and traceability
  • Risk management
  • Product development
  • Supplier control
  • Material handling
  • Production/process controls and infrastructure
  • Measurement, analysis and improvement – PMS and Vigilance
  • New EU Medical Device Regulations (MDR and IVDR)
  • MDSAP and ISO 13485

Learning objectives

Participants will learn how to effectively implement a quality management system in line with the requirements in QSReg, ISO 13485:2016, MDR and IVDR. Completion of this program will give you the knowledge needed to establish and implement a new quality management system or assess your current quality management system and implement improvements where needed. For further professional development this course may be combined with any of our two advanced courses to become “Auditor/Lead Auditor Pharmaceuticals and Medical Devices” (#5316) or “QA-RA Leader Medical Devices” (#5317). Read more about our complete training programs here » These two courses both serve as relevant preparation for a personal certification. The certification is optional and separate from the course. More information about personal certification is available at

Who should attend

The course is suitable for persons working with R&D, production, process development or QA who is involved in, or responsible for the operation or audit of a Quality Management System (QMS) for medical devices. Also those who need more knowledge about QSReg as well as the ISO 13485 standard and it’s relation to the new Medical Device regulations (MDR/IVDR) will benefit from this course.

  • You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company’s internal quality assurance programs.
  • You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).


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Date & Time
November 16, 2020
- November 18, 2020
09.00-17.00 CET
IndustryMedical Device

2 550,00 2 250,00

No. persons
3 persons or more 15% if registered and invoiced together for the same course.

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Åse Ek



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