systematic and compliant with requirements – The technical documentation is the central proof of compliance with regulatory requirements throughout the entire product life cycle and is therefore an essential basis for the conformity assessment. Mr. Gindlhumer – experienced auditor/technical expert in the area of ​​active medical devices with a focus on software – will provide you with the basics of the content and structure of technical documentation.

The event is aimed at all employees who are involved in the process of creating and maintaining technical documentation and for whom appropriate basic knowledge of the content and structure of technical documentation is required. In addition, the content is also relevant for those persons who are intended for the role of “person responsible for regulatory compliance” (PRRC – Article 15, MDR), but who have so far had little experience in connection with technical documentation.

• Purpose of the technical documentation
• Terms medical device file / technical documentation / DMR
• General requirements for TD
• Form and content of the TD
• Introduction Basic security and performance requirements
• Possibilities of providing evidence
• General aspects for medical devices
• Labelling
• Instructions for use
• UDI
• Biocompatibility
• Products for layperson use
• TD in market surveillance
• EU declaration of conformity

Participant discount: From the 2nd participant you will receive a discount of 15% on the net price.

Customer discount: mdc customers receive a 10% discount on the net price.

Participant and customer discounts cannot be combined!

Please note that the registration fee and the associated participation only applies to one person. If several people take part in the seminar (remotely) even though only one person has registered, we reserve the right to exclude them from the seminar.

450.00 Euro (plus value added tax)