The seminar deals with the development of documentation and evaluation of concepts in the context of biocompatibility. Medical devices that come into direct contact with the human body must fulfill their intended purpose without unacceptable biological risks to the patient. The ISO 10993 series of standards forms the framework for comprehensive and risk-based testing and evaluation of products. Dr. Loos, an experienced mdc expert in the field of biocompatibility, provides an overview of the regulatory and normative requirements for biological assessment and their implementation. The focus in Part I is on the standards of the ISO 10993 series and the requirements of the MDR.

Basics to get you started with the topic or to refresh it. In order to be able to carry out a biological assessment independently, Part II should also be followed.

• Presentation of legal requirements
• Carrying out the biological assessment as part of the risk management process (ISO 14971)
• Biological Grants Overview
• Presentation of relevant standards, overview of the ISO 10993 series
• Carrying out the biological assessment, structure and content of the plan and report

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! The discount will be deducted automatically if a booking concerns employees of the same company and the same seminar.

Please note that the registration fee and the associated participation only applies to one person. If several people take part in the remote-seminar, although only one person has registered, we reserve the right to exclude the further persons from the seminar.

450.00 Euro (plus value added tax)