The Management System EN ISO 13485:2016 defines quality management system standards for companies involved in one- or more stages of the medical device product cycle. Affected design and development, production, storage and sales, installation and maintenance of medical devices. Also, the departments design, development and provision of related operations (e.g. technical support) are concerned.

Topics:

  • Alterations in EN ISO 13485
  • Consequences of modified requirements on the Management System
  • Exchange within the group and recommendation for action

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Contact

Stephanie Rex
Veranstaltungsorganisation

T: +43 (0)5 0454-8129
E: stephanie.rex@tuv.at

Facts

Presence course

Training units: 8

Course fee: see course details - On request. Please note that this training course is offered as inhouse training.

Requirements: Basic knowledge EN ISO 13485:2012

Certification: Certificate of participation

Inhouse Trainings

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