Medical Devices DIN EN ISO 13485:2016-03

Medical Devices DIN EN ISO 13485:2016-03

Duration:1 lesson, 3 hours.

Participation: Videocall. In person meetings are suspanded due to Covid-19.


The standard ISO 13485:2016 follows the structure of the old ISO 9001 and requires companies in the medical device area to implement a quality management system (QMS) that accompanies and controls the entire product life cycle of a medical device. A good QMS is critical for companies to ensure that products and services meet customer needs and regulatory standards. ISO 13485 especially concentrates on the production of safe products for the customer and in some cases deviates from ISO 9001.

In recent decades, the quality has gone far beyond helping organisations comply with regulations and standards to help them improve. This will now support a wider shift in the industry towards better use of data to improve business processes.

During that time, the responsibility for maintaining and improving quality shifted from one department to all employees in the organisation (total quality management).

Target group & pre-requisite
Qualified Employees, managers and engineers.
Goals & benefits

This workshop helps to:

  • Define quality in general and a quality policy for your company.
  • Define and document systems, guidelines and procedures with reliable change control.
  • Publish your QMS and distribute it to all employees, including the supply chain.
  • Creation of a framework to demonstrate skills and competencies for training and development.
  • Verification and validation of products, processes and systems.
  • Verify compliance of policies and procedures through regular internal audit.
  • Check compliance with policies and procedures through regular internal audits.
  • Report incidents, near misses, and complaints, create action plans, and follow them to completion.
  • Analyze audits and results, incidents and events and determine causal factors and trends.