Medical Device Quality Management Systems (QMS)

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

(*MDR – EU Medical Device Regulation **QSR (QS Reg) – US Medical Device Regulation, 21 CFR 820)

In this training you will learn how to effectively implement and maintain a quality management system in line with the requirements in ISO 13485:2016, MDR/ IVDR and QS Reg.

Course description:

Do you sometimes struggle to reduce the burden of staying compliant, and yet build a quality system that serves the need of your organization? By attending this training you will get a thorough understanding of the intent of ISO 13485:2016, and how to deal with critical elements of the quality management system using a pragmatic and risk-based approach.

The content covers areas such as product development (design control), change control, manufacturing, process validation, management review, internal audits, CAPA management and post market surveillance.

The training provides you with the tools needed to establish a new quality management system or assess and improve your current quality management system, as required by the regulations.

Course outline

  • Managing a Quality System using PDCA and risk-based approach
  • Defining the role(s) of the organization and scope of the QMS.
  • Product development (design control)
  • Preventive and corrective actions – the CAPA system
  • Change control -how to assess and document changes, and notify changes to NB or CA
  • Supplier control and outsourcing, how to apply sufficient level of control
  • Document controls; interrelations and traceability
  • Management review – how to make most use of it.
  • Internal audits – plan, perform and follow-up
  • Differences between ISO13485:2016 and the US Quality System Regulation
  • Requirements on the Quality Management System, for MDR/IVDR compliance.

Learning objectives

Participants will learn how to:

  • Implement and maintain a quality management system in line with the requirements in ISO 13485:2016, QS Reg, and MDR/IVDR.
  • Evaluate effectiveness and compliance of the quality management system, using tools such as Internal Audits, Management Review and the CAPA system.
  • How to integrate risk management in your QMS and make real use of the risk-based approach, for example during change control.
  • How to perform efficient supplier audits, and decide when an audit is motivated.

Who should attend

This course is suitable for persons working with R&D, production, process development or QA either involved in, or responsible for the operation or audit of a Quality Management System (QMS) for medical devices. Anyone who need more knowledge about the US Quality System Regulation (QS Reg) as well as the ISO 13485 standard and its relation to the 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).

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


IndustryMedical Device
VenueDGI Byen

Åse Ek