Learning Objective

Manufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). The internationally recognized standard specifying requirements that a medical device QMS should meet is ISO 13485:2016 from the International Organization for Standardization. The US Quality Management System Regulation (QMSR) incorporates this standard by reference, and compliance with it is enforced by the US Food and Drug Administration (FDA) from 2 February 2026. This course lays out requirements of ISO 13485:2016 and the QMSR, setting them in the context of good manufacturing practices for medical devices.

Who will benefit from this module?

This course provides essential learning for all personnel involved in the manufacture of medical devices.

Learning Objectives

• Explain the importance of a medical device manufacturer’s quality management system, ISO 13485:2016, and the FDA’s Quality Management System Regulation
• State the responsibilities of top management for the QMS
• Identify documentation required in a QMS, and outline how it must be controlled
• Describe requirements for design and development, purchasing, and other pre-production processes
• Specify requirements that apply to the production of the device, its provision to the customer, and post-delivery activities
• Describe what measurement and analysis must be carried out to maintain product conformity and improve the QMS

Module Outline

Quality assurance and the quality management system
Manufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). In this session, we set out in general terms what a QMS is and why it is important, and we introduce a standard and a law that lay down requirements for a QMS.

Management responsibility
Top management is responsible for the development, implementation and maintenance of the QMS. They need to emphasize the importance of meeting customer and regulatory requirements, establish the quality policy, ensure that measurable quality objectives are formulated, conduct management reviews, and ensure the availability of resources. This session states the responsibilities of top management for the QMS.

Documentation requirements
A QMS is established and maintained through documentation that specifies what is to be done and by records of what has been done. In this session, we identify documentation that is essential to a QMS, and we emphasize the central role of the quality manual and the medical device file.

Pre-production processes
Product realization refers to all the processes that are implemented to successfully manufacture, deliver, install and service products that satisfy their safety and performance requirements. In this course we devote separate sessions to: pre-production processes, and production and service provision. In this session, we set out requirements for planning, customer communication, design and development, and purchasing, as well as control and monitoring of measurement equipment.

Production and service provision
In this session, we deal with the requirements that apply to the production of the device, its provision to the customer, and post-delivery activities.

Measurement, analysis and improvement
Under ISO 13485 and the QMSR, measurement and analysis must be carried out not only to maintain product conformity but also with a view to improving the QMS itself. In this session, we deal with requirements for obtaining feedback, handling complaints, reporting to regulators, auditing, monitoring and measurement of processes and product, control of nonconforming product, analysis of data, and improvement.

Level: Introductory/intermediate

Region: Europe, USA, other