A book with seven seals? The quality management standard ISO 13485 requires documenting procedures for validating the use of computer software in the quality management system. What is behind this requirement? What can or what must I do to meet this requirement? And how can I keep the effort within manageable limits? Mr. Sudmann (head of our Austria branch and long-time mdc auditor and technical expert) will get to the bottom of the requirements with you and present the tools to master the requirements of ISO 13485.

Managers and employees in quality management, development, production and IT who are or are to be entrusted with the validation of computer applications. We do not recommend any specific prior knowledge.

• Validations in ISO 13485
• Risk management and risk-based approach
• Life cycle of a software application
• Basic elements of a procedure for validating software applications
• Tools and methods

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)