The seminar shows the effects of DIN EN ISO 13485 and the EU-MDR on supplier qualification in medical technology for manufacturers/distributors.

The seminar explains how medical devices can be classified. Using practical examples, the criticality of the suppliers is determined, the risk assessment is carried out and the classification of the suppliers according to risk classes is determined. Furthermore, the quality assurance agreement is examined in an example of the criticality of medical devices. The impact of criticality on technical documentation and supplier audits is presented.

Topic overview

  • Criticality of suppliers according to DIN EN ISO 13485, chap. 4.1.2 and 4.1.3, the control of quality management processes and the associated process results
  • Risk assessment of purchasing processes/evaluation criteria
  • Classification of suppliers according to risk classes of medical devices
  • Impact on out-of-home processes
  • Influence on the quality assurance agreement and the technical documentation
  • Impact on supplier audits

target group

Employees from purchasing, QM and management, supplier auditors.

Prior knowledge


Funding opportunity

ESF funding is possible. Further information can be viewed here .

Early bird discount

If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.

Tuttlingen & Online


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