The technical documentation is considered the core of the conformity assessment process and central evidence documentation for the fulfillment of regulatory requirements. Mr. Gindlhumer – experienced auditor/technical expert in the area of ​​active medical devices with a focus on software – will explain the specifics of active medical devices to you.

The event is aimed at all employees who are involved in the process of creating and maintaining technical documentation and who require basic knowledge of the content and structure of technical documentation. 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.

• Essential Basic Safety and Performance Requirements for Active Medical Devices
• Electrical/Mechanical Safety
• radiation
• Measuring function
• Alarms
• EMC
• software
• Systems/combinations

Participant discount: From the 2nd participant you will receive a discount of 15% and from the 5th participant 25% 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 (zzgl. ges. MwSt)